Natural-Knee II Revision Femoral Spacer Lugs
FDA 510(k) K970498 · Intermedics Orthopedics
510(k) numberK970498
Submission
- Device name
- Natural-Knee II Revision Femoral Spacer Lugs
- Applicant
- Intermedics Orthopedics
Austin, TX, US - Received
- February 10, 1997
- Decision date
- April 30, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K970300 | Natural-Hip System Porous Stem with Ha/CstiLPH · Traditional | 07/03/1997SE |
| K970166 | Natural-Hip System Cocr Revision StemLZO · Traditional | 04/08/1997SE |
| K970567 | Select Shoulder Curved-Back Pegged All Poly GlenoidsKWT · Traditional | 02/27/1997SE |
| K964357 | Natural-Hip System Cocr StemLZO · Traditional | 01/27/1997SE |
| K964350 | Modula Options for Severe Bone Loss and TraumaJDI · Traditional | 01/16/1997SE |
| K962190 | Patellofemoral Joint ProsthesisKRR · Traditional | 10/28/1996SE |
| K963266 | Natural Hip System Porous Stem - Collarless, CollaredLPH · Traditional | 10/15/1996SE |
| K963155 | Intermoore Fracture Hip Stem (Modify)LWJ · Traditional | 10/01/1996SE |
| K962315 | Select Shoulder Cocr Humeral Stem ComponentKWT · Traditional | 09/03/1996SE |
| K962289 | Select Shoulder Cocr Humeral Stem ComponentHSD · Traditional | 08/29/1996SE |
Questions and answers
When was Natural-Knee II Revision Femoral Spacer Lugs cleared by the FDA?
Natural-Knee II Revision Femoral Spacer Lugs (K970498) received a 510(k) decision of Substantially Equivalent on April 30, 1997, 79 days after the submission was received.
What is the product code of K970498?
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.