Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patella Highly Cross Linked Ve Metal Backed Pa
FDA 510(k) K113756 · Encore Medical L.P.
Submission
- Device name
- Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patella Highly Cross Linked Ve Metal Backed Pa
- Applicant
- Encore Medical L.P.
Austin, TX, US - Received
- December 21, 2011
- Decision date
- March 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| 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 Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patella Highly Cross Linked Ve Metal Backed Pa cleared by the FDA?
Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patella Highly Cross Linked Ve Metal Backed Pa (K113756) received a 510(k) decision of Substantially Equivalent on March 14, 2012, 84 days after the submission was received.
What is the product code of K113756?
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.