Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=Od
FDA 510(k) K960424 · Endotec, Inc.
510(k) numberK960424
Submission
- Device name
- Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=Od
- Applicant
- Endotec, Inc.
Bloomfield, NJ, US - Received
- January 29, 1996
- Decision date
- August 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | Shoulder Innovations, Inc. | 09/08/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | Exactech, Inc. | 12/01/2025SE |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | Tornier, Inc. | 10/30/2025SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 03/10/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | Shoulder Innovations, Inc. | 02/11/2025SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 02/16/2024SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | Biomet Orthopedics | 07/12/2023SE |
| K222482 | AGILON XO Shoulder SystemKWT · Traditional | Implantcast GmbH | 09/28/2022SE |
| K210899 | LINK Embrace Shoulder System- Anatomical ConfigurationKWT · Traditional | Waldemar Link GmbH & Co. KG | 06/21/2021SE |
| K191698 | TiN Coated Humeral HeadKWT · Traditional | Fx Shoulder USA, Inc. | 07/16/2020SE |
More from Fx Shoulder USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081400 | Fanning-Pappas Modular Knee BearingJWH · Traditional | 02/20/2009SE |
| K012702 | Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1JWH · Traditional | 01/30/2002SE |
| K992394 | Buechel-Pappas Humeral Head Resurfacing ComponentHSD · Traditional | 10/15/1999SE |
| K982418 | Buechel-Pappas Modular Salvage StemMJT · Abbreviated | 04/29/1999SE |
| K963101 | B-P Hemispherical Acetabular ComponentLPH · Traditional | 02/12/1997SE |
| K963100 | Tronzo Acetabular Fixation Component (1 99-02-00XX (Ace. Fixation Cup) Xx=Od of Ace. CupLPH · Traditional | 02/12/1997SE |
| K960425 | Buechel-Pappas Polyethlene Acetabular COMPONENT(01-42-YYXX & 01-43-YYXXJDI · Traditional | 10/03/1996SE |
| K945254 | Electrosurgical Cutting & Coagulation Device AccessoriesGEI · Traditional | 06/06/1995SE |
| K944465 | Carrier, Ligature (79 Gej)GCJ · Traditional | 09/28/1994SE |
| K944414 | DekalbGCJ · Traditional | 09/27/1994SE |
Questions and answers
When was Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=Od cleared by the FDA?
Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=Od (K960424) received a 510(k) decision of Substantially Equivalent on August 26, 1996, 210 days after the submission was received.
What is the product code of K960424?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.