510(k) · Cleared
ClearedBurch/Schneider Reinforcement Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on May 3, 1996 as substantially equivalent to K953578 (Intermedics Orthopedics, 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995. 9 later devices descend from it.
- Decided
- May 3, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953578 (1995). 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK953578 Protek Acetabular Roof Reinforcement RingIntermedics Orthopedics · 1995
- This deviceK960678 Burch/Schneider Reinforcement CageIntermedics Orthopedics · 1996
- Descendant · cites it directly · 4 of its ownK061226 Trabecular Metal Acetabular Revision System CageZimmer, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK113296 ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or…Zimmer, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK971890 Recovery Protrusio CageBiomet, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK990032 Modular Protusio CupBiomet, Inc. · 1999 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K061226Trabecular Metal Acetabular Revision System CageZimmer, Inc. · 2006 · cites it directly4descendants
- K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc. · 2012 · 2 generations on2descendants
- K971890Recovery Protrusio CageBiomet, Inc. · 1997 · cites it directly2descendants
- K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · 2 generations on1descendant
- K990032Modular Protusio CupBiomet, Inc. · 1999 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953578 | Protek Acetabular Roof Reinforcement Ring | Intermedics Orthopedics | 1995 | — |
| 0 (this device) | K960678 | Burch/Schneider Reinforcement Cage | Intermedics Orthopedics | 1996 | — |
| +1 | K061226 | Trabecular Metal Acetabular Revision System Cage | Zimmer, Inc. | 2006 | — |
| +2 | K113296 | ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented… | Zimmer, Inc. | 2012 | — |
| +1 | K971890 | Recovery Protrusio Cage | Biomet, Inc. | 1997 | 1 |
| +2 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +1 | K990032 | Modular Protusio Cup | Biomet, Inc. | 1999 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953578 | Protek Acetabular Roof Reinforcement RingSummary page 1…urch Anti-Protrusio Reinforcement cage: Sulzer Orthopedics Limited (Preamendment Status) > Acetabular Roof Reinforcement Ring: Sulzer Orthopedics Limited (510(k) number K953578) > Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) number unknown to IOI). Device Description: The Burch/Schneider Reinfo… | 1995 |
| * | — | Preamendment H.B. Burch Anti-Protrusio Reinforcement Cage Named without a submission number | |
| * | — | Anti-Protrusio Reinforcement cage Named without a submission number |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (129 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960678 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960678: Burch/Schneider Reinforcement Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960678
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026