510(k) · Cleared
Recalled · Class II · 2021Hip Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 30, 2012 after a 90-day review. The FDA summary names no predicate by number. 21 later devices descend from it. It has been recalled 7 times.
- Decided
- Jul 30, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 7
- Predicates
- 0
21 later devices descend from it, 8 citing it directly.
- This deviceK121308 Hip SystemsHowmedica Osteonics Corp. · 2012
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · cites it directly · 8 of its ownK213129 Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021
- 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 · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K213129Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021 · cites it directly8descendants
- 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
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K121308 | Hip Systems | Howmedica Osteonics Corp. | 2012 | — |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +1 | K213129 | Restoration Modular 115mm Conical Distal Stem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021 | — |
| +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 | — |
| +2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (21)
See all 218 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 |
| K213129 | Restoration Modular 115mm Conical Distal Stem | 2021 | 8 |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | 2018 | 8 |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | 2020 | 6 |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | 2025 | 2 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained… | 2026 | 0 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | 2024 | 0 |
| K193233 | Restoration® Modular Hip System | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 30, 2021 | Class II | Z-0651-2022 | Labeling mix-ups | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. |
| Dec 30, 2021 | Class II | Z-0652-2022 | Labeling mix-ups | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. |
| Dec 21, 2021 | Class II | Z-0644-2022 | Under Investigation by firm | There is a potential for the outer Tyvek lid to de-bond from the sealed package. |
| Oct 3, 2019 | Class II | Z-0514-2020 | Employee error | Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) |
| Jul 21, 2017 | Class II | Z-0940-2018 | Process control | Inner and outer sterile barriers not fully sealed. |
| Jul 21, 2017 | Class II | Z-0941-2018 | Process control | Inner and outer sterile barriers not fully sealed. |
| Sep 8, 2015 | Class II | Z-0261-2016 | Process design | Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The overall indications for use for the subject total and hemi hip replacement prostheses 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…
Read the full statement (188 words)
The overall indications for use for the subject total and hemi hip replacement prostheses 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 Rejuvenate Hip System is intended for cementless use only.
Additional indications specific to the Hipstar Stem:
The Hipstar Femoral Stem is intended for cementless use only.
When mated with a constrained acetabular liner the Hipstar Stem is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Additional indications specific to the Restoration Modular Hip System:
The Restoration Modular Hip System is intended for primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121308: Hip Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121308
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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