Axiom Total Knee System, A/P Curved Tibial Insert
FDA 510(k) K912894 · Orthomet, Inc.
510(k) numberK912894
Submission
- Device name
- Axiom Total Knee System, A/P Curved Tibial Insert
- Applicant
- Orthomet, Inc.
Minneapolis, MN, US - Received
- July 1, 1991
- Decision date
- October 18, 1991
- 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 |
|---|---|---|
| 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 Axiom Total Knee System, A/P Curved Tibial Insert cleared by the FDA?
Axiom Total Knee System, A/P Curved Tibial Insert (K912894) received a 510(k) decision of Substantially Equivalent on October 18, 1991, 109 days after the submission was received.
What is the product code of K912894?
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.