510(k) · Cleared
ClearedPrecision Osteolock Femoral Stems with Pure-Fix HA Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Aug 13, 1999 as substantially equivalent to K912395 (Howmedica Corp., 1991) after a 58-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 13, 1999
- Review
- 58 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912395 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912395 Howmedica Precis Osteolock Fem Comp W/Hydro CoatHowmedica Corp. · 1991
- This deviceK992025 Precision Osteolock Femoral Stems with Pure-Fix HA CoatingHowmedica Osteonics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912395 | Howmedica Precis Osteolock Fem Comp W/Hydro Coat | Howmedica Corp. | 1991 | — |
| 0 (this device) | K992025 | Precision Osteolock Femoral Stems with Pure-Fix HA Coating | Howmedica Osteonics Corp. | 1999 | — |
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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K912395 | Howmedica Precis Osteolock Fem Comp W/Hydro CoatSummary page 1…tification is to describe a modification to the Precision® Osteolock Femoral Stems with Hydroxyapatite Coating (previously determined substantially equivalent via 510(k) K912395). It is the intention of Howmedica Osteonics to change the hydroxyapatite coating on these femoral stems from the Low Pressure Pl… | 1991 |
| † | K896047 | The Omnifit Epf Hip Joint Femoral Stem | 1990 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis. This femoral stem is intended to…
Read the full statement (132 words)
This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis.
This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52’ taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.
The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.
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/K992025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992025: Precision Osteolock Femoral Stems with Pure-Fix HA Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992025
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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