Second Generation Knee System, Femoral, Patellar
FDA 510(k) K895145 · Orthomet, Inc.
510(k) numberK895145
Submission
- Device name
- Second Generation Knee System, Femoral, Patellar
- Applicant
- Orthomet, Inc.
Minneapolis, MN, US - Received
- August 18, 1989
- Decision date
- July 6, 1990
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K936310 | Orthomet HMC Femoral Stem ComponentLPH · Traditional | 06/07/1995SE |
| K945783 | Orthomet Titanium Hybrid Femoral StemJDG · Traditional | 05/30/1995SE |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SyLXH · Traditional | 04/26/1995SE |
| K944752 | Orthomet Resurfacing Femoral ComponentKXA · Traditional | 12/28/1994SE |
| K930771 | Perfecta Total Hip System Coated Cocr Femoral StemJDI · Traditional | 11/30/1994SN |
| K926334 | Axiom Total Knee Syst/Acl Retain Tibial Tray/InserJWH · Traditional | 10/18/1994SN |
| K932677 | Axiom Total Knee SystemJWH · Traditional | 10/14/1994SE |
| K931678 | Orthomet LHMC Femoral StemHMC · Traditional | 10/14/1994SE |
| K931333 | Orthomet Acetabular Cup SystemLPH · Traditional | 10/14/1994SE |
| K925536 | Hybrid Femoral Stem, Perfecta Total Hip SystemKWY · Traditional | 01/07/1994SN |
Questions and answers
When was Second Generation Knee System, Femoral, Patellar cleared by the FDA?
Second Generation Knee System, Femoral, Patellar (K895145) received a 510(k) decision of Substantially Equivalent for Some Indications on July 6, 1990, 322 days after the submission was received.
What is the product code of K895145?
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.