510(k) · Cleared
ClearedReflection Acetabular Reinforcement Rings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Cleared on Sep 17, 1996 after an 81-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Sep 17, 1996
- Review
- 81 days
- Class
- Class II
- Product code
- JDJ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK962541 Reflection Acetabular Reinforcement RingsSmith & Nephew Richards, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK040680 Contour HA Coated Reconstruction RingSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK171073 Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK092098 Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K040680Contour HA Coated Reconstruction RingSmith & Nephew, Inc. · 2004 · cites it directly6descendants
- K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. · 2017 · cites it directly5descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc. · 2010 · cites it directly1descendant
- K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962541 | Reflection Acetabular Reinforcement Rings | Smith & Nephew Richards, Inc. | 1996 | — |
| +1 | K040680 | Contour HA Coated Reconstruction Ring | Smith & Nephew, Inc. | 2004 | — |
| +1 | K171073 | Smith & Nephew, Inc. REDAPT Augments | Smith & Nephew, Inc. | 2017 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +1 | K092098 | Patient Specific Acetabular Reconstruction Prosthesis | Smith & Nephew, Inc. | 2010 | — |
| +2 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners… | Smith & Nephew, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 JDJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | — | Trilogy™ Acetabular System - Zimmer Named without a submission number | |
| * | — | Porous Ringloc Acetabular System - Biomet Named without a submission number | |
| * | — | S-ROM™ Oblong Component - Joint Medical Products Corporation Named without a submission number | |
| * | — | MARS® Ringloc Component - Biomet Named without a submission number | |
| * | — | Healey Flanged Component - Biomet Named without a submission number | |
| * | — | Original M.E. Miiller Acetabular Roof Reinforcement Ring - Protek Ltd. Named without a submission number | |
| * | — | H.B. Burch- R. Schneider Reinforcement Cage Named without a submission number | |
| * | — | R. Ganz Acetabular Roof Reinforcement Ring with Hook - Intermedics Named without a submission number | |
| * | — | Gap Acetabular Cup - Osteonics Named without a submission number | |
| * | — | Oh-Harris Protrusio Shell - Howmedica Named without a submission number |
What descends from it? (9)
5 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?
- Of its descendants, K040680 (Smith & Nephew, Inc., 2004) has gone furthest, with 6 descendants of its own.
How does its category compare?
All JDJ devicesJDJ Mesh, Surgical, Acetabular, Hip, Prosthesis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDJ
FDA has decided no JDJ device since 2007.
Median 510(k) review, days · JDJ
Too few JDJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JDJ
No recall names JDJ since 2007.
Adverse event reports per year · JDJ
2in 2025
MAUDE reports naming product code JDJ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings are…
Read the full statement (95 words)
The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously. The device is for single use.
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/K962541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962541: Reflection Acetabular Reinforcement Rings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962541
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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