REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
FDA 510(k) K242377 · Osteoremedies, LLC
510(k) numberK242377
Submission
- Device name
- REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
- Applicant
- Osteoremedies, LLC
Germantown, TN, US - Received
- August 9, 2024
- Decision date
- October 2, 2024
- 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 |
|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular CupKWL · Special | 07/24/2026SE |
| K253675 | OsteoRemedies Hip Spacer SystemKWL · Special | 12/23/2025SE |
| K250760 | SPECTRUM GV Bone CementLOD · Special | 04/02/2025SE |
| K231556 | SPECTRUM® GV Bone CementLOD · Traditional | 12/20/2023SE |
| K223650 | REMEDY Stemmed Knee SpacerJWH · Special | 01/05/2023SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | 08/23/2019SE |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerJWH · Traditional | 07/25/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | 08/29/2018SE |
| K173967 | Remedy Acetabular CupKWL · Traditional | 02/22/2018SE |
Questions and answers
When was REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component cleared by the FDA?
REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component (K242377) received a 510(k) decision of Substantially Equivalent on October 2, 2024, 54 days after the submission was received.
What is the product code of K242377?
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.