Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1
FDA 510(k) K012702 · Endotec, Inc.
510(k) numberK012702
Submission
- Device name
- Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1
- Applicant
- Endotec, Inc.
South Orange, NJ, US - Received
- August 14, 2001
- Decision date
- January 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 510(k) | Device | Decision |
|---|---|---|
| K081400 | Fanning-Pappas Modular Knee BearingJWH · Traditional | 02/20/2009SE |
| 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 |
| 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 (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1 cleared by the FDA?
Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1 (K012702) received a 510(k) decision of Substantially Equivalent on January 30, 2002, 169 days after the submission was received.
What is the product code of K012702?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.