# K960678: Burch/Schneider Reinforcement Cage

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: May 3, 1996 after 77 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953578 (1995). 1 ancestor in all.
9 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953578: Protek Acetabular Roof Reinforcement Ring, Intermedics Orthopedics (1995) Summary page 1.
- (no number) Preamendment H.B. Burch Anti-Protrusio Reinforcement Cage: named in the summary without a submission number
- (no number) Anti-Protrusio Reinforcement cage: named in the summary without a submission number

## Most influential descendants
- K061226: Trabecular Metal Acetabular Revision System Cage (2006), 4 descendants of its own
- K113296: ZMR Hip System  KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (2012), 2 descendants of its own
- K971890: Recovery Protrusio Cage (1997), 2 descendants of its own
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own
- K990032: Modular Protusio Cup (1999), 1 descendant of its own

## Indications for use
The Burch/Schneider Reinforcement Cage is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Burch/Schneider Reinforcement Cage, like the predicate devices, is intended to provide support for an all polyethylene acetabular implant in a cemented application. Diagnostic indications for use of this device include, but are not limited to, acetabular dysplasia, osteoporosis, protrusio 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 Burch/Schneider Reinforcement Cage in total hip arthroplasty include: 1. Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis, 2. Fracture or avascular necrosis of the femoral head, 3. Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

Source page: https://510kreport.com/device/K960678
Methodology: https://510kreport.com/methodology