Ortholoc Advantim Revision Femoral Component
FDA 510(k) K932210 · Dow Corning Wright
510(k) numberK932210
Submission
- Device name
- Ortholoc Advantim Revision Femoral Component
- Applicant
- Dow Corning Wright
Arlington, TN, US - Received
- May 7, 1993
- Decision date
- September 7, 1994
- 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 |
|---|---|---|
| K932911 | Ortholoc Advantim L.S. Tibial ComponentJWH · Traditional | 06/30/1994SN |
| K934354 | Lacey All Polyethylene Tibial ComponentJWH · Traditional | 06/03/1994SE |
| K932222 | SLT Femoral HeadLZO · Traditional | 05/27/1994SE |
| K932858 | Ortholoc Advantim Tibial Base ComponentJWH · Traditional | 02/16/1994SE |
| K930228 | Ortholoc Advantim Tibial Stem 5 DegreeJWH · Traditional | 11/30/1993SE |
| K925900 | Lacey Revision Femoral ComponentJWH · Traditional | 08/24/1993SE |
| K930189 | Ortholoc(R) Advantim(Tm) Posterior Stab Femor CompJWH · Traditional | 08/06/1993SN |
| K930188 | Ortholoc(R) Advantim(Tm) Femoral ComponentJWH · Traditional | 08/03/1993SE |
| K930190 | Ortholoc(R) Advantim(Tm) Non-Por Coat Femor CompJWH · Traditional | 08/02/1993SE |
| K926257 | Ortholoc Advantim Thick Tibial Base ComponentJWH · Traditional | 05/18/1993SE |
Questions and answers
When was Ortholoc Advantim Revision Femoral Component cleared by the FDA?
Ortholoc Advantim Revision Femoral Component (K932210) received a 510(k) decision of Substantially Equivalent for Some Indications on September 7, 1994, 488 days after the submission was received.
What is the product code of K932210?
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.