510(k) · Cleared
Recalled · Class II · 2014Citation TMZF 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 Jan 21, 2000 as substantially equivalent to K972228 (Howmedica, Inc., 1997) and 2 other predicates after a 74-day review. Its family tree reaches back 2 generations to 1994. 224 later devices descend from it. It has been recalled 12 times.
- Decided
- Jan 21, 2000
- Review
- 74 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 12
- Predicates
- 3
Its longest line of descent runs back 2 generations to K941141 (1994). 6 ancestors in all. 224 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
- 1 generation backK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
- This deviceK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 3 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 3 generations on · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
Showing 5 of 224 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 224 · See all- K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · cites it directly150descendants
- K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · cites it directly101descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 3 generations on83descendants
- K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · 3 generations on68descendants
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) | K993768 | Citation TMZF HA Stem | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| +2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +3 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +3 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 13 | 0 |
| 2017 | 19 | 0 |
| 2018 | 10 | 0 |
| 2019 | 16 | 0 |
| 2020 | 13 | 0 |
| 2021 | 13 | 0 |
| 2022 | 15 | 0 |
| 2023 | 12 | 0 |
| 2024 | 12 | 0 |
| 2025 | 21 | 0 |
| 2026 | 11 | 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? (3)
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…al equivalence of the Citation TMZF HA Stems is based upon equivalence in intended use, materials, design, and operational principles to Meridian® Titanium Femoral Stem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); and the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366). Testi… | 1997 |
| * | K955871 | Howmedica Asymmetric Stem Femoral ComponentSummary page 1…quivalence in intended use, materials, design, and operational principles to Meridian® Titanium Femoral Stem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); and the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366). Testing indicates that the addition of the HA coating over plasma… | 1996 |
| * | K941366 | Osteonics Omnifit AD-HA Hip Stem SeriesSummary page 1…l principles to Meridian® Titanium Femoral Stem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); and the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366). Testing indicates that the addition of the HA coating over plasma spray has no effect on the stem fatigue strength. For infor… | 1995 |
What descends from it? (224)
See all 2243 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2014 | Class II | Z-1317-2014 | Error in labeling | Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right… |
| Jan 6, 2009 | Not classified | Z-1374-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Jan 6, 2009 | Not classified | Z-1381-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Jan 6, 2009 | Not classified | Z-1379-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Jan 6, 2009 | Not classified | Z-1380-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Jan 6, 2009 | Not classified | Z-1378-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Jan 6, 2009 | Not classified | Z-1376-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Jan 6, 2009 | Not classified | Z-1375-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Jan 6, 2009 | Not classified | Z-1382-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Jan 6, 2009 | Not classified | Z-1377-2009 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Nov 12, 2002 | Not classified | Z-0349-03 | Other | Hip Stem Fractures in the neck area. |
| Nov 12, 2002 | Not classified | Z-0350-03 | Other | Hip Stem Fractures in the neck area. |
The 5 latest of 12 recalls; the web page lists all.
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 6 ancestors have a recall of any class.
- Of its descendants, K001448 (Howmedica Osteonics Corp., 2000) has gone furthest, with 150 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 Citation TMZF HA Stem is 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 it can be used in treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. It is 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/K993768 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993768: Citation TMZF 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/K993768
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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