510(k) · Cleared
Recalled · Class II · 2024Total Hip Femoral Heads and Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 2, 2002 as substantially equivalent to K993259 (Sulzer Orthopedics, Inc., 2000) and 3 other predicates after a 26-day review. Its family tree reaches back 3 generations to 1996. 162 later devices descend from it. It has been recalled once.
- Decided
- Oct 2, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K955033 (1996). 6 ancestors in all. 162 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 2 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 1 generation backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- This deviceK022958 Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 149 of its ownK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 140 of its ownK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- Descendant · 3 generations on · 110 of its ownK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- Descendant · 3 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · 4 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
Showing 5 of 162 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 162 · See all- K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009 · cites it directly149descendants
- K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010 · 2 generations on140descendants
- K103120Corin Biolox Delta Femoral HeadsCorin USA · 2011 · 3 generations on110descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 3 generations on109descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 4 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −2 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −1 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| 0 (this device) | K022958 | Total Hip Femoral Heads and Liners | Smith & Nephew, Inc. | 2002 | — |
| +1 | K083762 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2009 | — |
| +2 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| +3 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| +3 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +4 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 15 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 10 | 0 |
| 2017 | 9 | 0 |
| 2018 | 10 | 0 |
| 2019 | 12 | 0 |
| 2020 | 10 | 0 |
| 2021 | 7 | 0 |
| 2022 | 14 | 0 |
| 2023 | 13 | 0 |
| 2024 | 10 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 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? (6)
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 |
|---|---|---|---|
| * | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSummary page 1…orous-coated uncemented prosthesis: Class I1 Substantial Equivalence Information The Total Hip Femoral Heads are substantially equivalent to Sulzer Inter-Op CoCr heads (K993259), Osteonics Alumina C-Taper Heads (K003391), and currently marketed heads distributed by Smith & Nephew. The Total Hip Liners are… | 2000 |
| * | K003391 | Osteonics Alumina C-Taper HeadSummary page 1…1 Substantial Equivalence Information The Total Hip Femoral Heads are substantially equivalent to Sulzer Inter-Op CoCr heads (K993259), Osteonics Alumina C-Taper Heads (K003391), and currently marketed heads distributed by Smith & Nephew. The Total Hip Liners are substantially equivalent to Sulzer Inter-O… | 2000 |
| * | K002575 | Inter-OP Durasul Acetabular Inserts (4MM)Summary page 1…), and currently marketed heads distributed by Smith & Nephew. The Total Hip Liners are substantially equivalent to Sulzer Inter-Op Durasul Acetabular Inserts (K993259 & K002575), DePuy Duraloc Acetabular Cup System (KO 10 17 I), and Smith 8( Nephew crosslinked polyethyelene liners. Device Description The… | 2000 |
| * | K010171 | Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner | 2001 |
| * | — | Currently marketed heads distributed by Smith & Nephew Named without a submission number | |
| * | — | Smith & Nephew crosslinked polyethylene liners Named without a submission number |
What descends from it? (162)
See all 1626 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083762 | Biolox Delta Ceramic Femoral Heads | 2009 | 149 |
| K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe Liners | 2010 | 16 |
| K081566 | Smith & Nephew Oxinium DH Femoral Heads | 2008 | 8 |
| K110101 | Taper Oxinium Femoral Head | 2011 | 5 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2024 | Class II | Z-1901-2024 | Process control | Packaging contained the incorrect size of femoral head from what was displayed on the label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K083762 (Smith & Nephew, Inc., 2009) has gone furthest, with 149 descendants of its own.
- 4 other devices also cite its predicate K993259.
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?
Total hip components are indicated for individuals undergoing primary and 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 (107 words)
Total hip components are indicated for individuals undergoing primary and 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; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022958 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022958: Total Hip Femoral Heads and Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022958
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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