Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts
FDA 510(k) K103223 · Encore Medical L.P.
Submission
- Device name
- Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts
- Applicant
- Encore Medical L.P.
Austin, TX, US - Received
- November 1, 2010
- Decision date
- December 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OIY – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.
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| K252887 | DePuy ATTUNE Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 05/22/2026SE |
| K242665 | DePuy ATTUNE Total Knee SystemOIY · Traditional | Depuy Orthopedics, Inc. | 11/01/2024SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | DePuy Orthopaedics, Inc. | 06/18/2020SE |
| K120038 | A200 Knee SystemOIY · Traditional | Renovis Surgical Technologies, LLC | 02/14/2013SE |
| K121727 | Movation Knee SystemOIY · Special | Encore Medical L.P. | 08/15/2012SE |
| K113756 | Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patella Highly…OIY · Special | Encore Medical L.P. | 03/14/2012SE |
| K111433 | Depuy Sttune (TM) PS Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 08/30/2011SE |
| K103756 | Depuy Attune Total Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 03/15/2011SE |
| K101433 | Depuy Attune Knee SystemOIY · Traditional | DePuy Orthopaedics, Inc. | 12/10/2010SE |
| K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712OIY · Traditional | Encore Medical L.P. | 09/28/2010SE |
More from Encore Medical L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K252567 | AltiVate Reverse® ADLC GlenospherePHX · Traditional | 01/15/2026SE |
| K252974 | EMPOWR KneeJWH · Traditional | 12/19/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | 11/12/2025SE |
| K252141 | AltiVate Reverse® GlenoidPHX · Special | 08/05/2025SE |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)JWH · Special | 07/08/2025SE |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)JWH · Traditional | 07/02/2025SE |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…PHX · Special | 05/16/2025SE |
| K241483 | ceramys femoral head systemLZO · Traditional | 02/07/2025SE |
| K233481 | AltiVate Reverse® GlenoidPHX · Traditional | 05/29/2024SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | 06/23/2023SE |
Questions and answers
When was Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts cleared by the FDA?
Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts (K103223) received a 510(k) decision of Substantially Equivalent on December 21, 2010, 50 days after the submission was received.
What is the product code of K103223?
The FDA product code is OIY – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive, a Class II (moderate risk) device regulated under 21 CFR 888.3560.