510(k) · Cleared
Recalled · 2008Secur-Fit HA and Secur-Fit Plus Hip Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Nov 9, 2004 as substantially equivalent to K941366 (Osteonics Corp., 1995) and 4 other predicates after a 189-day review. Its family tree reaches back 1 generation to 1995. 18 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 9, 2004
- Review
- 189 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 1 generation to K941366 (1995). 5 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK941366 Osteonics Omnifit AD-HA Hip Stem SeriesOsteonics Corp. · 1995 · Recalled
- This deviceK041170 Secur-Fit HA and Secur-Fit Plus Hip StemsHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 2 generations on · 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
- Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · 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 · 2 generations on8descendants
- 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
- K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941366 | Osteonics Omnifit AD-HA Hip Stem Series | Osteonics Corp. | 1995 | 1 |
| 0 (this device) | K041170 | Secur-Fit HA and Secur-Fit Plus Hip Stems | Howmedica Osteonics Corp. | 2004 | — |
| +1 | 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 |
| +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 | — |
| +2 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 |
|---|---|---|---|
| * | K941366 | Osteonics Omnifit AD-HA Hip Stem SeriesSummary page 2…ially equivalent to the corresponding features of the predicate Osteonics ® Secur-FitTM HA and Secur-FitTM Plus Hip Stems determined substantially equivalent via 510(k)s K941366, K951517, 982032, K990203, and K020615. The modified stems are similar to the predicate stems in every aspect with the exception… | 1995 |
| * | K951517 | Osteonics Secur-Fit HA Plus Hip Stem SeriesSummary page 2…ivalent to the corresponding features of the predicate Osteonics ® Secur-FitTM HA and Secur-FitTM Plus Hip Stems determined substantially equivalent via 510(k)s K941366, K951517, 982032, K990203, and K020615. The modified stems are similar to the predicate stems in every aspect with the exception of the st… | 1996 |
| * | K982032 | Osteonics Omnifit HA Hip Stem Series, Osteonics Secur-Fit HA Hip Stem Series, Osteonics…Summary page 2…o the corresponding features of the predicate Osteonics ® Secur-FitTM HA and Secur-FitTM Plus Hip Stems determined substantially equivalent via 510(k)s K941366, K951517, 982032, K990203, and K020615. The modified stems are similar to the predicate stems in every aspect with the exception of the streamline… | 1998 |
| * | K990203 | Osteonics Primary Secur-Fit Plus Hip StemsSummary page 2…rresponding features of the predicate Osteonics ® Secur-FitTM HA and Secur-FitTM Plus Hip Stems determined substantially equivalent via 510(k)s K941366, K951517, 982032, K990203, and K020615. The modified stems are similar to the predicate stems in every aspect with the exception of the streamlined neck ge… | 1999 |
| * | K020615 | Super Secur-Fit HA Hip Stems and Super Secur-Fit Plus HA Hip StemsSummary page 2…eatures of the predicate Osteonics ® Secur-FitTM HA and Secur-FitTM Plus Hip Stems determined substantially equivalent via 510(k)s K941366, K951517, 982032, K990203, and K020615. The modified stems are similar to the predicate stems in every aspect with the exception of the streamlined neck geometry and th… | 2002 |
What descends from it? (18)
See all 181 later device cites 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 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2008 | Not classified | Z-0893-2009 | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. |
| Nov 13, 2008 | Not classified | Z-0894-2009 | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Osteonics® Secur-FitTM HA and Secur-FitTM Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The indications for use of the Osteonics ® Secur-FitTM HA and Secur-FitTM Plus Hip Stems as a Total Hip Replacement include: * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; * Rheumatoid arthritis; · Correction of…
Read the full statement (100 words)
The Osteonics® Secur-FitTM HA and Secur-FitTM Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
The indications for use of the Osteonics ® Secur-FitTM HA and Secur-FitTM Plus Hip Stems as a Total Hip Replacement 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 non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041170: Secur-Fit HA and Secur-Fit Plus Hip Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041170
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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