Anatomical Type Knee System
FDA 510(k) K922859 · Osteo Technology, Inc.
510(k) numberK922859
Submission
- Device name
- Anatomical Type Knee System
- Applicant
- Osteo Technology, Inc.
Timonium, MD, US - Received
- June 4, 1992
- Decision date
- September 23, 1993
- 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 |
|---|---|---|
| K926156 | Replica(Tm) Total Hip SystemLPH · Traditional | 03/09/1994SN |
| K922869 | Total Condylat Type Knee SystemJWH · Traditional | 07/13/1993SE |
| K925447 | Oti Orthopedic Wire SystemJDQ · Traditional | 06/29/1993SE |
| K926213 | Modified Zickel Intramedullary Rod SystemHSB · Traditional | 06/17/1993SE |
| K922861 | Biometric Screw Fixation CupJDL · Traditional | 05/12/1993SE |
| K922870 | Three Spike CupGRF · Traditional | 04/08/1993SE |
| K925301 | Oti Orthopedic Fastener SystemHTY · Traditional | 03/16/1993SE |
| K922682 | Americana Hip ProthesisJDG · Traditional | 03/16/1993SE |
| K922871 | Unifit Femoral StemJDI · Traditional | 02/12/1993SE |
| K922868 | Thompson Type Hip ProthesisKWA · Traditional | 02/12/1993SE |
Questions and answers
When was Anatomical Type Knee System cleared by the FDA?
Anatomical Type Knee System (K922859) received a 510(k) decision of Substantially Equivalent on September 23, 1993, 476 days after the submission was received.
What is the product code of K922859?
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.