510(k) · Cleared
ClearedOsteonics Restoration Acetabular Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Cleared on Jun 3, 1997 after a 78-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Jun 3, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- JDJ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK970957 Osteonics Restoration Acetabular RingOsteonics Corp. · 1997
- Descendant · cites it directly · 6 of its ownK040680 Contour HA Coated Reconstruction RingSmith & Nephew, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK092098 Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040680Contour HA Coated Reconstruction RingSmith & Nephew, Inc. · 2004 · cites it directly6descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · 2 generations on3descendants
- K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc. · 2010 · 2 generations on1descendant
- K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · 3 generations on0descendants
- K242375OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970957 | Osteonics Restoration Acetabular Ring | Osteonics Corp. | 1997 | — |
| +1 | K040680 | Contour HA Coated Reconstruction Ring | Smith & Nephew, Inc. | 2004 | — |
| +2 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K092098 | Patient Specific Acetabular Reconstruction Prosthesis | Smith & Nephew, Inc. | 2010 | — |
| +3 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners… | Smith & Nephew, Inc. | 2024 | — |
| +3 | K242375 | OR3O Dual Mobility System | 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 |
| 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? (4)
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 |
|---|---|---|---|
| * | — | Osteonics Restoration Acetabular Cup Series Named without a submission number | |
| * | — | Osteonics Omnifit Cup Inserts Named without a submission number | |
| * | — | Osteonics Concentric Polyethylene Acetabular Cup Named without a submission number | |
| * | — | Osteonics Flanged Polyethylene Acetabular Cup Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040680 | Contour HA Coated Reconstruction Ring | 2004 | 6 |
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 indications for the use of the Osteonics® Restoration Acetabular Rings, in keeping with those of other legally marketed Osteonics acetabular components, are as follows: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management…
Read the full statement (100 words)
The indications for the use of the Osteonics® Restoration Acetabular Rings, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Class II cavitary or protrusio defects.
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/K970957 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970957: Osteonics Restoration Acetabular Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970957
Report an extraction error
Are you the manufacturer?
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