510(k) · Cleared
Recalled · Class II · 2016Exeter Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Sep 27, 2011 as substantially equivalent to K011623 (Howmedica Osteonics Corp., 2001) and 6 other predicates after a 238-day review. Its family tree reaches back 4 generations to 1996. 37 later devices descend from it. It has been recalled once.
- Decided
- Sep 27, 2011
- Review
- 238 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 4 generations to K955033 (1996). 20 ancestors in all, the oldest K900836 (1990). 37 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 3 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 2 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 1 generation backK061434 Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 2006 · Recalled
- This deviceK110290 Exeter Hip StemHowmedica Osteonics Corp. · 2011
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · cites it directly · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
- Descendant · cites it directly · 7 of its ownK152084 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with…Corentec Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · cites it directly8descendants
- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
- K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd. · 2016 · cites it directly7descendants
- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −3 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −2 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −1 | K061434 | Trident Large Diameter Hip System | Howmedica Osteonics Corp. | 2006 | 2 |
| 0 (this device) | K110290 | Exeter Hip Stem | Howmedica Osteonics Corp. | 2011 | — |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +1 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +2 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
| +1 | K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with… | Corentec Co., Ltd. | 2016 | 1 |
| +2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (7)
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 |
|---|---|---|---|
| * | K011623 | Exeter Hip System with V40 TaperSummary page 2…ntial Equivalence: The Exeter® hip stem continues to be manufactured from the same material via the same process and same design as the Exeter& hips that were cleared in K01 1623. The Exeter® Hip Stems are substantially equivalent to other commercially available hip arthroplasty, systems in regards to indic… | 2001 |
| * | K972228 | Meridian Titanium Femoral StemsSummary page 2…als, and operational principles. The femoral head compatibility of the Exeter Hip Stem is substantially equivalent to Meridian TMZF Femoral Hip Stem that was cleared via K972228 .The following devices are examples of predicate systems currently cleared for use that will now be intend for compatible usage w… | 1997 |
| * | K993601 | Howmedica Osteonics Femoral HeadsSummary page 2…ystems currently cleared for use that will now be intend for compatible usage with the Exeter® stems: Howmedica Osteonics' V4OTM taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757) and Universal Taper Biolox® Delta Ceramic heads with a titanium alloy adaptor sleeve (K070885). Summ… | 1999 |
| * | K022077 | 36MM V40 Femoral Head Components (Lfit and Non-Lfit)Summary page 2…rrently cleared for use that will now be intend for compatible usage with the Exeter® stems: Howmedica Osteonics' V4OTM taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757) and Universal Taper Biolox® Delta Ceramic heads with a titanium alloy adaptor sleeve (K070885). Summary of Te… | 2002 |
| * | K061434 | Trident Large Diameter Hip SystemSummary page 2…leared for use that will now be intend for compatible usage with the Exeter® stems: Howmedica Osteonics' V4OTM taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757) and Universal Taper Biolox® Delta Ceramic heads with a titanium alloy adaptor sleeve (K070885). Summary of Technologie… | 2006 |
| * | K010757 | Lfit V40 Femoral Head ComponentsSummary page 2…r use that will now be intend for compatible usage with the Exeter® stems: Howmedica Osteonics' V4OTM taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757) and Universal Taper Biolox® Delta Ceramic heads with a titanium alloy adaptor sleeve (K070885). Summary of Technologies: The te… | 2001 |
| * | K070885 | Universal Taper Delta Femoral HeadSummary page 2…V4OTM taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757) and Universal Taper Biolox® Delta Ceramic heads with a titanium alloy adaptor sleeve (K070885). Summary of Technologies: The technological characteristics (material, design, sizes, and operational… | 2007 |
What descends from it? (37)
See all 377 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | 2018 | 8 |
| K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &… | 2016 | 7 |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | 2020 | 6 |
| K172857 | Latitud Hip Replacement System | 2018 | 5 |
| K142761 | Corin TaperFit Hip Stem | 2015 | 4 |
| K180973 | Libertas Hip Replacement System | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2016 | Class II | Z-2396-2016 | Device Design | Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
- 8 other devices also cite its predicate K011623.
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. 2011, this device’s year, is highlighted.
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?
The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only.
The Exeter® Hip is indicated for:
* noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
* rheumatoid arthritis;
* correction of functional deformity;
* revision procedures where other treatments or devices have failed; and
* treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
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/K110290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110290: Exeter Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110290
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