510(k) · Cleared
ClearedOvation Tribute Hip Stem; Ovation Narrow Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 11, 2014 as substantially equivalent to K062775 (Ortho Development Corp., 2007) and 3 other predicates after a 126-day review. Its family tree reaches back 7 generations to 1985. 3 later devices descend from it.
- Decided
- Mar 11, 2014
- Review
- 126 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K850055 (1985). 100 ancestors in all, the oldest K830313 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 6 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 5 generations backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 4 generations backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- 3 generations backK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK080625 Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled
- This deviceK133386 Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp. · 2014
- Descendant · cites it directly · 2 of its ownK171249 Entrada™ hip stemOrtho Development Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK233758 Trivicta™ Hip StemOrtho Development Corp. · 2024
- Descendant · 3 generations on · 0 of its ownK251052 Trivicta® Hip StemOrtho Development Corp. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −6 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −5 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| −4 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| −3 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| −2 | K080625 | Smith & Nephew Mis Hip Stem with Stiktite | Smith & Nephew, Inc. | 2008 | 1 |
| −1 | K103256 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2011 | 2 |
| 0 (this device) | K133386 | Ovation Tribute Hip Stem; Ovation Narrow Hip Stem | Ortho Development Corp. | 2014 | — |
| +1 | K171249 | Entrada™ hip stem | Ortho Development Corporation | 2017 | — |
| +2 | K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024 | — |
| +3 | K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 15 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 24.3 · 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? (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 |
|---|---|---|---|
| * | K062775 | European Style Taper,Press-Fit Hip StemSummary page 1…porous-coated uncemented prosthesis DEVICE PRODUCT CODE: LPH PREDICATE DEVICES: OvationO Hip Stem, Ortho Development (K062775) Ovation 10/12 Hip Stem, Ortho Development (K<131022) Ta… | 2007 |
| * | K131022 | Ovation 10/12 Hip StemSummary page 3…similarities to the predicate devices, and a review of the testing, the devices are substantially equivalent to femoral stem components that were cleared under K062775, K131022, K110400, and K103256. Ovation Tribute & Ovation Narrow Hip Stems 510(k) Section 5, 510(k) Summary… | 2013 |
| * | K110400 | Taperloc Complete Microplasty StemSummary page 3…ties to the predicate devices, and a review of the testing, the devices are substantially equivalent to femoral stem components that were cleared under K062775, K131022, K110400, and K103256. Ovation Tribute & Ovation Narrow Hip Stems 510(k) Section 5, 510(k) Summary === Page… | 2011 |
| * | K103256 | Smith & Nephew SMF Hip StemSummary page 3…redicate devices, and a review of the testing, the devices are substantially equivalent to femoral stem components that were cleared under K062775, K131022, K110400, and K103256. Ovation Tribute & Ovation Narrow Hip Stems 510(k) Section 5, 510(k) Summary DEPA… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171249 | Entrada™ hip stem | 2017 | 2 |
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?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 24 of the 99 ancestors have a recall of any class.
- Of its descendants, K171249 (Ortho Development Corporation, 2017) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K062775.
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. 2014, 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?
1. Notably impaired hipjolint due to ostcoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
2. Previously tailed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avosculor necrosis of femoral head.
5. Non-union of proximal femnoral neck fractures.
6. Treatment of fractures that are unmanageable using other foyms of therapy.
7. Benign or malignant bone tumors, congenital dysplasla or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133386: Ovation Tribute Hip Stem; Ovation Narrow Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133386
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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