Template
FDA product code HWT · Class I (low risk) · 21 CFR 888.4800 · Orthopedic
10510(k) clearances
0PMA approvals
70recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974406 | OrthoplanHWT · Traditional | Ortho-Graphics, Inc. | 02/18/1998SE |
| K960685 | Orthodoc Preoperative Planner Model 500HWT · Traditional | Integrated Surgical Systems, Inc. | 01/17/1997SE |
| K894228 | Kronner Spherical CuttersHWT · Traditional | Kronner Medical | 07/23/1990SE |
| K870843 | Schultz Phalangeal Comp Trial/Metacarpal Comp TriaHWT · Traditional | Warsaw Orthopedic, Inc. | 05/27/1987SE |
| K871323 | Arthroscopic Meniscal Suture SystemHWT · Traditional | Orthopedic Systems, Inc. | 05/01/1987SE |
| K830360 | 3M Osteotomy GuideHWT · Traditional | 3M Company | 03/01/1983SE |
| K811205 | Molded Polysulfone Trial ProsthesisHWT · Traditional | Shannon Group | 05/21/1981SE |
| K781091 | Knee Instrumentation, CondylarHWT · Traditional | Biomet, Inc. | 07/17/1978SE |
| K771710 | Worrell Patella TemplateHWT · Traditional | Depuy, Inc. | 10/06/1977SE |
| K771709 | Worrell Trial PatellaHWT · Traditional | Depuy, Inc. | 10/06/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2445-2024 Class II | LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the… | Link Bio Corp | 06/27/2024Open, Classified |
| Z-1569-2022 Class II | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK | Materialise USA LLC | 07/13/2022Completed |
| Z-1419-2022 Class II | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the…Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring.… | DePuy Orthopaedics, Inc. | 06/29/2022Open, Classified |
| Z-1463-2018 Class II | The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under…Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred… | Integra LifeSciences Corp. | 12/20/2017Terminated |
| Z-0591-2018 Class II | NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee…The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size… | Aesculap Implant Systems LLC | 08/10/2017Terminated |
| Z-2073-2017 Class II | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600Part of the number on the tray lid differ from the part number on the base. | Biomet Microfixation, LLC | 04/11/2017Terminated |
| Z-2262-2015 Class II | FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and… | Encore Medical, Lp | 06/24/2015Terminated |
| Z-2065-2015 Class II | Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford…Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference… | Biomet, Inc. | 06/03/2015Terminated |
| Z-0075-2015 Class II | Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow…An investigation identified that the product was incorrectly manufactured as a left humeral trial but is… | Biomet, Inc. | 09/24/2014Terminated |
| Z-1437-2014 Class II | GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019…Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons… | DePuy Orthopaedics, Inc. | 03/28/2014Terminated |
| Z-0463-2014 Class II | NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | Zimmer, Inc. | 11/19/2013Terminated |
| Z-0462-2014 Class II | NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | Zimmer, Inc. | 11/19/2013Terminated |
| Z-0461-2014 Class II | NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | Zimmer, Inc. | 11/19/2013Terminated |
| Z-2080-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2079-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2078-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2077-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2076-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2075-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2074-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2073-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2072-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2071-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2070-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2069-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2068-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2067-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2066-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2065-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2064-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2063-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2062-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2061-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-2060-2013 Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem…The trial stems were manufactured using the wrong design. | Waldemar Link GmbH & Co. KG (Corp. Hq.) | 07/16/2013Terminated |
| Z-1520-2013 Class II | DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is…The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled… | DePuy Orthopaedics, Inc. | 05/03/2013Terminated |
| Z-2114-2012 Class II | Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial…The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part… | Aesculap Implant Systems LLC | 07/12/2012Terminated |
| Z-2484-2012 Class II | 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2483-2012 Class II | 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2482-2012 Class II | 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2481-2012 Class II | 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2480-2012 Class II | 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2479-2012 Class II | 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2478-2012 Class II | 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2477-2012 Class II | 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2476-2012 Class II | 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2475-2012 Class II | 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2474-2012 Class II | 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-2473-2012 Class II | 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | Zimmer, Inc. | 04/01/2011Terminated |
| Z-0619-2011 | Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF…Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts. | Zimmer Inc. | 11/15/2010Terminated |
| Z-0400-2013 Class II | 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14…Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to… | Zimmer, Inc. | 10/10/2010Terminated |