510(k) · Cleared
ClearedSmith & Nephew Modular Femoral (Hemi) Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Sep 12, 2006 as substantially equivalent to K061243 (Smith & Nephew, Inc., 2006) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1990. 18 later devices descend from it.
- Decided
- Sep 12, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K896580 (1990). 3 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK896580 Uni-Polar HeadRichards Medical Co., Inc. · 1990
- 1 generation backK061243 Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc. · 2006 · Recalled
- This deviceK062408 Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK113848 R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK161233 OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK102370 R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 5 of its ownK191002 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · cites it directly16descendants
- K113848R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · 2 generations on7descendants
- K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016 · 2 generations on6descendants
- K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011 · 2 generations on6descendants
- K191002OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2019 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896580 | Uni-Polar Head | Richards Medical Co., Inc. | 1990 | — |
| −1 | K061243 | Smith & Nephew Modular Femoral Head | Smith & Nephew, Inc. | 2006 | 1 |
| 0 (this device) | K062408 | Smith & Nephew Modular Femoral (Hemi) Head | Smith & Nephew, Inc. | 2006 | — |
| +1 | K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | Smith & Nephew, Inc. | 2010 | — |
| +2 | K113848 | R3 Xlpe Liners | Smith & Nephew, Inc. | 2012 | 2 |
| +2 | K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016 | — |
| +2 | K102370 | R3 Xlpe Anteverted Liners | Smith & Nephew, Inc. | 2011 | — |
| +3 | K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K061243 | Smith & Nephew Modular Femoral HeadSummary page 1…y-available Smith & Nephew femoral sx'Žam. The overall design of the component is based upon the existing Smith & Nephew Modular Heads and Uni-potar implants subject of K061243 and K(896580, respectively. C. SUBSTANTIAL EOUI VALENCE INFORMATION: The Smith & Nephew Modular Femoral (Hemi) Heads are simi… | 2006 |
| * | K896580 | Uni-Polar HeadSummary page 1…ly available devices regarding design features, overall indications, and materials: * Smith & Nephew Modular Femoral Heads (1K061243) * Smith &Nephew Uni-Polar Head (K896580) DEPARTMENT OF HE.ATH & HUMAN SERVICES Public Health Service… | 1990 |
What descends from it? (18)
See all 183 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K093363 (Smith & Nephew, Inc., 2010) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K061243.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Smith & Nephew Modular Femoral Heads are indicated for the following: * Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; * rheumatoid arthritis; * arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; * revision procedures where other treatments have failed; and *…
Read the full statement (108 words)
The Smith & Nephew Modular Femoral Heads are indicated for the following:
* Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
* rheumatoid arthritis;
* arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
* revision procedures where other treatments have failed; and
* treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062408: Smith & Nephew Modular Femoral (Hemi) Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062408
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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