# K102424: Prevision Hip System with Recon Ring

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Dec 9, 2010 after 106 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K955033 (1996). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992667: ZMR Hip System-Revision Taper, Zimmer, Inc. (1999) Summary page 1.
- K994286: ZMR Hip System-Porous Revision, Zimmer, Inc. (2000) Summary page 1.
- K960678: Burch/Schneider Reinforcement Cage, Intermedics Orthopedics (1996) Summary page 1.
- K071916: Metha Hip System, Aesculap Implant Systems, Inc. (2008) Summary page 1.
- K040191: Bicontact Hip Stem and Femoral Head, Aesculap (2004) Summary page 1.

## Indications for use
The Prevision Hip System is intended for cementless revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The Prevision Hip System is intended for revision only. The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. Inaddition, the Recon Ring is intended to provide support for an all polyethylene acetabular implant in a cemented application. Diagnostic indications for use of this device include acetabular dlysplasia, osteoporosis, protrusion acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery. The general indications associated with the use of the Recon Ring in total hip arthroplasty include: * Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis, * Fracture or avascular necrosis of the femoral head, * Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

Source page: https://510kreport.com/device/K102424
Methodology: https://510kreport.com/methodology