510(k) · Cleared
Recalled · Class II · 2012TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem
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 Mar 16, 2000 as substantially equivalent to K972228 (Howmedica, Inc., 1997) and 3 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1994. 76 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 16, 2000
- Review
- 80 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 2 generations to K941141 (1994). 7 ancestors in all, the oldest K921301 (1994). 76 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
- 1 generation backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
- This deviceK994366 TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 53 of its ownK103479 Novel Tapered Hip StemStryker Corp. · 2011
- Descendant · cites it directly · 46 of its ownK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- Descendant · 2 generations on · 30 of its ownK123604 Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · Recalled
- Descendant · 2 generations on · 22 of its ownK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- Descendant · 2 generations on · 21 of its ownK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K103479Novel Tapered Hip StemStryker Corp. · 2011 · cites it directly53descendants
- K120578Accolade II Hip StemHowmedica Osteonics · 2012 · cites it directly46descendants
- K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · 2 generations on30descendants
- K122853Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013 · 2 generations on22descendants
- K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics · 2015 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941141 | Precision Ostelock SP Femoral Component | Howmedica Corp. | 1994 | — |
| −1 | K972228 | Meridian Titanium Femoral Stems | Howmedica, Inc. | 1997 | — |
| 0 (this device) | K994366 | TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| +1 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| +2 | K123604 | Abg Iii Monolithic Hip Stem | Howmedica Osteonics Corp. | 2013 | 1 |
| +2 | K122853 | Novel Fit and Fill Stem | Howmedica Osteonics Corp. | 2013 | — |
| +2 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 3 | 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 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? (4)
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 |
|---|---|---|---|
| * | K972228 | Meridian Titanium Femoral StemsSummary page 1…HA Stem and TMZF® Press Fit Plus HA Stem is based upon equivalence in intended use, materials, design, and operational principles to the Meridian® Titanium Femoral Stem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366); and the Bi… | 1997 |
| * | K955871 | Howmedica Asymmetric Stem Femoral ComponentSummary page 1…alence in intended use, materials, design, and operational principles to the Meridian® Titanium Femoral Stem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366); and the Biomet® Taperloc™ Hip System (K921301). Testing indicates tha… | 1996 |
| * | K941366 | Osteonics Omnifit AD-HA Hip Stem SeriesSummary page 1…l principles to the Meridian® Titanium Femoral Stem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366); and the Biomet® Taperloc™ Hip System (K921301). Testing indicates that the addition of the HA coating over plasma spray has no… | 1995 |
| * | K921301 | Taperloc Femoral Stem and Universal Acetabular ComSummary page 1…tem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366); and the Biomet® Taperloc™ Hip System (K921301). Testing indicates that the addition of the HA coating over plasma spray has no detectable effect on the stem fatigue strength.… | 1994 |
What descends from it? (76)
See all 766 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103479 | Novel Tapered Hip Stem | 2011 | 53 |
| K120578 | Accolade II Hip Stem | 2012 | 46 |
| K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 | 20 |
| K051741 | Accolade HFX Femoral Stem | 2005 | 18 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K052542 | Accolade RPS Hip Stem | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2012 | Class II | Z-0656-2013 | Labeling mix-ups | Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix. |
| Jul 14, 2011 | Not classified | Z-0075-2012 | Mixed-up of materials/components | Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem. |
| Mar 1, 2011 | Not classified | Z-2557-2011 | Employee error | Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K103479 (Stryker Corp., 2011) has gone furthest, with 53 descendants of its own.
- 4 other devices also cite its predicate K972228.
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?
The TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem are indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally, these femoral stems can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. These stems are also indicated for use in revision procedures where other treatments or devices have failed.
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/K994366 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994366: TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994366
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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