Buechel-Pappas Humeral Head Resurfacing Component
FDA 510(k) K992394 · Endotec, Inc.
510(k) numberK992394
Submission
- Device name
- Buechel-Pappas Humeral Head Resurfacing Component
- Applicant
- Endotec, Inc.
South Orange, NJ, US - Received
- July 19, 1999
- Decision date
- October 15, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3690
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233260 | Univers Revers CA Head and AdapterHSD · Traditional | Arthrex, Inc. | 02/12/2024SE |
| K221232 | Univers Revers Humeral Cup ImplantHSD · Special | Arthrex, Inc. | 05/19/2022SE |
| K191433 | AGILON® XO Shoulder Replacement SystemHSD · Traditional | Implantcast GmbH | 11/12/2020SE |
| K193122 | Biocore9 Humeral Resurfacing SystemHSD · Traditional | Biocore9, LLC | 05/15/2020SE |
| K173964 | OVOMotion Shoulder Arthroplasty SystemHSD · Traditional | Arthrosurface, Inc. | 04/18/2018SE |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional | Arthrex, Inc. | 11/21/2016SE |
| K161620 | Anatomical Shoulder Domelock Dome centricHSD · Traditional | Zimmer GmbH | 11/01/2016SE |
| K151527 | Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional | Arthrex, Inc. | 04/19/2016SE |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special | Arthrosurface, Inc. | 12/19/2014SE |
| K131298 | Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional | Exactech, Inc. | 11/26/2013SE |
More from Exactech, 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 |
| 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 |
| K960424 | Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=OdKWT · Traditional | 08/26/1996SE |
| 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 Humeral Head Resurfacing Component cleared by the FDA?
Buechel-Pappas Humeral Head Resurfacing Component (K992394) received a 510(k) decision of Substantially Equivalent on October 15, 1999, 88 days after the submission was received.
What is the product code of K992394?
The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.