510(k) · Cleared
Recalled · Class II · 2025Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
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 Aug 13, 2020 as substantially equivalent to K111848 (Stryker Corp., 2011) and 6 other predicates after a 247-day review. Its family tree reaches back 10 generations to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Aug 13, 2020
- Review
- 247 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 10 generations to K921308 (1994). 127 ancestors in all, the oldest K894124 (1989). 6 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 6 generations between
- 3 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- 2 generations backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- 1 generation backK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- This deviceK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020
- Descendant · cites it directly · 5 of its ownK213701 Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
- Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 3 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · 3 generations on · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
- Descendant · 3 generations on · 0 of its ownK250989 Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025
Show all 10 generations
- Root · 10 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 9 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 8 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 7 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 6 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
- 5 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- 4 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- 3 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- 2 generations backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- 1 generation backK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- This deviceK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · cites it directly5descendants
- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
- K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on2descendants
- K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 3 generations on0descendants
- K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −9 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −8 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −7 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −6 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| −5 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| −4 | K122853 | Novel Fit and Fill Stem | Howmedica Osteonics Corp. | 2013 | — |
| −3 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
| −2 | 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 |
| 0 (this device) | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020 | — |
| +1 | K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022 | — |
| +2 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +3 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +3 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | 2 |
| +3 | K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 6 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | K111848 | Exeter X3 Rimfit Acetabular CupSummary page 5…sis (21 CFR §888.3390) Product Codes: JDI, LZO, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: x Exeter X3 RimFit Cup (K111848) x Exeter V40 Femoral Stem (K011623, K052718, K110290, K121308, K153345, K173499) Legally Marketed Reference Device… | 2011 |
| * | K011623 | Exeter Hip System with V40 TaperSummary page 5…JDI, LZO, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: x Exeter X3 RimFit Cup (K111848) x Exeter V40 Femoral Stem (K011623, K052718, K110290, K121308, K153345, K173499) Legally Marketed Reference Devices Used to Support Substantial Equivalence… | 2001 |
| * | K052718 | V40 Biolox Delta Ceramic Femoral HeadsSummary page 5…JDI, LZO, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: x Exeter X3 RimFit Cup (K111848) x Exeter V40 Femoral Stem (K011623, K052718, K110290, K121308, K153345, K173499) Legally Marketed Reference Devices Used to Support Substantial Equivalence: x… | 2005 |
| * | K110290 | Exeter Hip StemSummary page 5…, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: x Exeter X3 RimFit Cup (K111848) x Exeter V40 Femoral Stem (K011623, K052718, K110290, K121308, K153345, K173499) Legally Marketed Reference Devices Used to Support Substantial Equivalence: x Trident®,… | 2011 |
| * | K121308 | Hip SystemsSummary page 5…Y Legally Marketed Device to Which Substantial Equivalence is Claimed: x Exeter X3 RimFit Cup (K111848) x Exeter V40 Femoral Stem (K011623, K052718, K110290, K121308, K153345, K173499) Legally Marketed Reference Devices Used to Support Substantial Equivalence: x Trident®, Restorat… | 2012 |
| * | K153345 | Stryker Orthopaedics Hip Systems Labeling UpdateSummary page 5…ly Marketed Device to Which Substantial Equivalence is Claimed: x Exeter X3 RimFit Cup (K111848) x Exeter V40 Femoral Stem (K011623, K052718, K110290, K121308, K153345, K173499) Legally Marketed Reference Devices Used to Support Substantial Equivalence: x Trident®, Restoration ADM®,… | 2016 |
| * | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsSummary page 5…ce to Which Substantial Equivalence is Claimed: x Exeter X3 RimFit Cup (K111848) x Exeter V40 Femoral Stem (K011623, K052718, K110290, K121308, K153345, K173499) Legally Marketed Reference Devices Used to Support Substantial Equivalence: x Trident®, Restoration ADM®, and MDM® X3 UHM… | 2018 |
| † | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | 2019 |
| † | K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | 2017 |
| † | K191414 | EXETER Centralizer, EXETER 2.5mm Plug | 2019 |
| † | K173849 | Triathlon Total Knee System | 2018 |
| † | K171768 | Trident® II Acetabular System | 2017 |
| † | K174399 | Unnamed device |
What descends from it? (6)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class II | Z-2640-2025 | Under Investigation by firm | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 46 of the 127 ancestors have a recall of any class.
- Of its descendants, K213701 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2022) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K111848.
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. 2020, 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 indications for use for total hip arthroplasty include: * 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…
Read the full statement (179 words)
The indications for use for total hip arthroplasty include:
* 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 inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
The Exeter X3 RimFit Cup is intended for cemented use only.
The indications for use for total and hemi hip arthroplasty include:
* 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.
The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.
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/K193429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193429
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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