Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners
FDA 510(k) K120370 · Zimmer, Inc.
Submission
- Device name
- Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- February 6, 2012
- Decision date
- June 4, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and…
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| K143647 | Renovis Surgical Hip Replacement SystemOQG · Traditional | Renovis Surgical Technologies, Inc. | 05/11/2015SE |
| K140130 | X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…OQG · Traditional | Encore Medical L.P. | 11/06/2014SE |
| K141972 | Klassic HD Acetabular Insert with E-Link PolyOQG · Traditional | Total Joint Orthopedics, Inc. | 10/09/2014SE |
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| K252623 | G7® Revision Acetabular SystemLPH · Traditional | 02/04/2026SE |
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Questions and answers
When was Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners cleared by the FDA?
Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (K120370) received a 510(k) decision of Substantially Equivalent on June 4, 2012, 119 days after the submission was received.
What is the product code of K120370?
The FDA product code is OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.