Duracon Total Knee System Tibial Components
FDA 510(k) K915512 · Pfizer Hospital Products Group, Inc.
510(k) numberK915512
Submission
- Device name
- Duracon Total Knee System Tibial Components
- Applicant
- Pfizer Hospital Products Group, Inc.
Rutherford, NJ, US - Received
- December 9, 1991
- Decision date
- August 18, 1992
- 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 |
|---|---|---|
| K930156 | Mega Plus Super Lag ScrewKTT · Traditional | 02/22/1994SE |
| K920831 | Pca Total Hip System (Cementless Use)LPH · Traditional | 06/10/1992SE |
| K920034 | Duracon Modular Femoral Component and Femoral SpacJWH · Traditional | 03/18/1992SE |
| K915184 | Howmedica Alumina Femoral HeadLZO · Traditional | 01/31/1992SE |
| K911656 | Pleur-Evac Plus Contin. Reinfus. & Autoinfus. SystCAC · Traditional | 08/13/1991SE |
| K911292 | Schneider Wallstent(R)FGE · Traditional | 05/01/1991SE |
| K905482 | Bondek Polyglycolic Acid Synthetic Absorb. SutureGAM · Traditional | 03/14/1991SE |
Questions and answers
When was Duracon Total Knee System Tibial Components cleared by the FDA?
Duracon Total Knee System Tibial Components (K915512) received a 510(k) decision of Substantially Equivalent for Some Indications on August 18, 1992, 253 days after the submission was received.
What is the product code of K915512?
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.