Lacey All Polyethylene Tibial Component
FDA 510(k) K934354 · Dow Corning Wright
510(k) numberK934354
Submission
- Device name
- Lacey All Polyethylene Tibial Component
- Applicant
- Dow Corning Wright
Arlington, TN, US - Received
- September 7, 1993
- Decision date
- June 3, 1994
- 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 |
|---|---|---|
| K932210 | Ortholoc Advantim Revision Femoral ComponentJWH · Traditional | 09/07/1994SN |
| K932911 | Ortholoc Advantim L.S. Tibial ComponentJWH · Traditional | 06/30/1994SN |
| 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 Lacey All Polyethylene Tibial Component cleared by the FDA?
Lacey All Polyethylene Tibial Component (K934354) received a 510(k) decision of Substantially Equivalent on June 3, 1994, 269 days after the submission was received.
What is the product code of K934354?
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.