510(k) · Cleared
ClearedContour HA Coated Reconstruction Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Jun 14, 2004 as substantially equivalent to K962541 (Smith & Nephew Richards, Inc., 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.
- Decided
- Jun 14, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K962007 (1996). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK962007 Protrusion CagesDepuy, Inc. · 1996
- This deviceK040680 Contour HA Coated Reconstruction RingSmith & Nephew, Inc. · 2004
- 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
- Descendant · 2 generations on · 0 of its ownK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK231448 TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K242375OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024 · 2 generations on0descendants
- K231448TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962007 | Protrusion Cages | Depuy, Inc. | 1996 | — |
| 0 (this device) | K040680 | Contour HA Coated Reconstruction Ring | Smith & Nephew, Inc. | 2004 | — |
| +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 | — |
| +2 | K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024 | — |
| +2 | K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | K962541 | Reflection Acetabular Reinforcement RingsSummary page 1…BSTANTIAL EQUIVALENCE INFORMATION: The Contour HA Coated Reconstruction Ring is substantially equivalent to the Smith & Nephew Reflection Acetabular Reinforcement Rings (K962541), Osteonics Restoration Acetabular Ring (K970957), and DePuy Protrusio Cage (K962007). The Contour HA Coated Reconstruction Ring… | 1996 |
| * | K970957 | Osteonics Restoration Acetabular RingSummary page 1…Coated Reconstruction Ring is substantially equivalent to the Smith & Nephew Reflection Acetabular Reinforcement Rings (K962541), Osteonics Restoration Acetabular Ring (K970957), and DePuy Protrusio Cage (K962007). The Contour HA Coated Reconstruction Ring has a HA coating that is substantially equivalent… | 1997 |
| * | K962007 | Protrusion CagesSummary page 1…antially equivalent to the Smith & Nephew Reflection Acetabular Reinforcement Rings (K962541), Osteonics Restoration Acetabular Ring (K970957), and DePuy Protrusio Cage (K962007). The Contour HA Coated Reconstruction Ring has a HA coating that is substantially equivalent to the HA coating on the Smith & Ne… | 1996 |
| † | K922621 | HA TI-Fit Acetabular and Femoral Component | 1994 |
| † | K990666 | Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit… | 1999 |
What descends from it? (6)
3 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 MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the…
Read the full statement (157 words)
Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip and correction of deformity.
Acetabular reinforcement and reconstruction 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 wail deficiency, and/or protrusion as a result of the indications listed previously. The device is intended for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040680 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040680: Contour HA Coated Reconstruction Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040680
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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