510(k) · Cleared
ClearedExeter® X3® RimFit® Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp., Dba Stryker Orthopaedics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Feb 1, 2022 as substantially equivalent to K193429 (Howmedica Osteonics Corp., 2020) and 1 other predicate after a 69-day review. Its family tree reaches back 11 generations to 1994. 5 later devices descend from it.
- Decided
- Feb 1, 2022
- Review
- 69 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K921308 (1994). 128 ancestors in all, the oldest K894124 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 7 generations between
- 3 generations backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- 2 generations backK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- 1 generation backK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
- This deviceK213701 Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
- Descendant · cites it directly · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 2 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · 2 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 · 2 generations on · 0 of its ownK250989 Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025
- Descendant · cites it directly · 0 of its ownK240418 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
Show all 11 generations
- Root · 11 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 10 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 9 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 8 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 7 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
- 6 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- 5 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- 4 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- 3 generations backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- 2 generations backK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- 1 generation backK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
- This deviceK213701 Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
Most influential descendants
Showing 5 of 5 · See all- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
- K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on2descendants
- K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
- K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025 · 2 generations on0descendants
- K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −10 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −9 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −8 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −7 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| −6 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| −5 | K122853 | Novel Fit and Fill Stem | Howmedica Osteonics Corp. | 2013 | — |
| −4 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
| −3 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| −2 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| −1 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020 | 1 |
| 0 (this device) | K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022 | — |
| +1 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +2 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +2 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | 2 |
| +2 | K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025 | — |
| +1 | K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit CupSummary page 4…DI, LZO, JDG, KWY Legally Marketed Device to Which Substantial Equivalence is Claimed: • Primary Predicate Device: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (K193429) • Secondary Predicate Device: Exeter X3 RimFit Acetabular Cup (K111848) • Reference Device: Zimmer ZCA All-Poly Acetab… | 2020 |
| * | K111848 | Exeter X3 Rimfit Acetabular CupSummary page 4…is Claimed: • Primary Predicate Device: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (K193429) • Secondary Predicate Device: Exeter X3 RimFit Acetabular Cup (K111848) • Reference Device: Zimmer ZCA All-Poly Acetabular Cups (K191449)… | 2011 |
| † | K191449 | ZCA All-Poly Acetabular Cups | 2020 |
What descends from it? (5)
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)
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 28 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 47 of the 128 ancestors have a recall of any class.
- Of its descendants, K233498 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2023) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K193429.
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. 2022, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213701: Exeter® X3® RimFit® Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213701
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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