510(k) · Cleared
ClearedStryker Orthopaedics Hip Systems Labeling Update
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 Apr 12, 2024 as substantially equivalent to K213701 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2022) and 4 other predicates after a 59-day review. Its family tree reaches back 21 generations to 1994.
- Decided
- Apr 12, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 21 generations to K941847 (1994). 319 ancestors in all, the oldest K800207 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 17 generations between
- 3 generations backK211703 Insignia Hip StemStryker Orthopaedics · 2021
- 2 generations backK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- 1 generation backK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- This deviceK240418 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
Show all 21 generations
- Root · 21 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 20 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 19 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 18 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 17 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 16 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 15 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 14 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 13 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 12 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 11 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 10 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 9 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 8 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 7 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 6 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 5 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 4 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- 3 generations backK211703 Insignia Hip StemStryker Orthopaedics · 2021
- 2 generations backK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- 1 generation backK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- This deviceK240418 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −20 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −19 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −18 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −17 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −16 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −15 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −14 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −13 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −12 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −11 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −10 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −9 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −8 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −7 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −6 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −5 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| −4 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| −3 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
| −2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
| −1 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 7 | 0 |
| 1992 | 7 | 0 |
| 1993 | 5 | 0 |
| 1994 | 27 | 0 |
| 1995 | 19 | 0 |
| 1996 | 20 | 0 |
| 1997 | 14 | 0 |
| 1998 | 15 | 0 |
| 1999 | 8 | 0 |
| 2000 | 24 | 0 |
| 2001 | 14 | 0 |
| 2002 | 22 | 0 |
| 2003 | 13 | 0 |
| 2004 | 10 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 10 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K213701 | Exeter® X3® RimFit® CupSummary page 7…nonporous uncemented prosthesis. Product Codes: JDI, JDQ, HRS, LRN, LYT, LPH, JDG, KWY, LZO Primary Predicate Device to Which Substantial Equivalence is Claimed: K213701: Exeter® X3® RimFit® Cup… | 2022 |
| * | K233498 | Stryker Orthopaedics Hip Systems Labeling UpdateSummary page 8…2 4 Additional Predicate Device Used to Support Substantial Equivalence: K233498: Stryker Orthopaedics Hip Systems Labeling Update K202016: Dall-Miles® Cable System K121308: HIP SYSTEMS K19… | 2023 |
| * | K202016 | Dall-Miles® Cable SystemSummary page 8…2 4 Additional Predicate Device Used to Support Substantial Equivalence: K233498: Stryker Orthopaedics Hip Systems Labeling Update K202016: Dall-Miles® Cable System K121308: HIP SYSTEMS K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Reason for… | 2020 |
| * | K121308 | Hip SystemsSummary page 8…redicate Device Used to Support Substantial Equivalence: K233498: Stryker Orthopaedics Hip Systems Labeling Update K202016: Dall-Miles® Cable System K121308: HIP SYSTEMS K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Reason for 510(k) Submission: the labeling of the… | 2012 |
| * | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit CupSummary page 8…ort Substantial Equivalence: K233498: Stryker Orthopaedics Hip Systems Labeling Update K202016: Dall-Miles® Cable System K121308: HIP SYSTEMS K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Reason for 510(k) Submission: the labeling of the subject Stryker Orthopaedics… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 10 companies; a new generation was cleared every 1.4 years on median.
- 85 of the 318 ancestors have a recall of any class.
- 1 other device also cites its predicate K213701.
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. 2024, 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?
DALL-MILES Cable System The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach. The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment…
Read the full statement (631 words)
DALL-MILES Cable System
The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
Femoral Heads
The indications for use for total hip and hemi hip arthroplasty include:
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Femoral Mesh
The indications for use for total hip and hemi hip arthroplasty include:
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality.
Intramedullary Plug, Centralizer
The indications for use of total hip replacement prostheses 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 Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.
The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.
Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:
1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. 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.
Femoral Stems
The indications for use for total hip and hemi hip arthroplasty include:
1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. 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/K240418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240418: Stryker Orthopaedics Hip Systems Labeling Update.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240418
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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