510(k) · Cleared
ClearedOvation 10/12 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 Oct 16, 2013 as substantially equivalent to K062775 (Ortho Development Corp., 2007) and 3 other predicates after a 187-day review. Its family tree reaches back 5 generations to 1997. 5 later devices descend from it.
- Decided
- Oct 16, 2013
- Review
- 187 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to P960047 (1997). 39 ancestors in all, the oldest K830313 (1983). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 4 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
- 3 generations backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
- 2 generations backK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- 1 generation backK062775 European Style Taper,Press-Fit Hip StemOrtho Development Corp. · 2007 · Recalled
- This deviceK131022 Ovation 10/12 Hip StemOrtho Development Corp. · 2013
- Descendant · cites it directly · 3 of its ownK133386 Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp. · 2014
- Descendant · 2 generations on · 2 of its ownK171249 Entrada™ hip stemOrtho Development Corporation · 2017
- Descendant · 3 generations on · 1 of its ownK233758 Trivicta™ Hip StemOrtho Development Corp. · 2024
- Descendant · 4 generations on · 0 of its ownK251052 Trivicta® Hip StemOrtho Development Corp. · 2025
- Descendant · cites it directly · 0 of its ownK132697 Encompass 10/12 Hip StemOrtho Development Corp. · 2014
Most influential descendants
Showing 5 of 5 · See all- K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp. · 2014 · cites it directly3descendants
- K171249Entrada™ hip stemOrtho Development Corporation · 2017 · 2 generations on2descendants
- K233758Trivicta™ Hip StemOrtho Development Corp. · 2024 · 3 generations on1descendant
- K251052Trivicta® Hip StemOrtho Development Corp. · 2025 · 4 generations on0descendants
- K132697Encompass 10/12 Hip StemOrtho Development Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −4 | K021728 | Ringloc Constrained Liners II | Biomet, Inc. | 2002 | — |
| −3 | K030047 | Freedom Constrained Liners | Biomet, Inc. | 2003 | — |
| −2 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| −1 | K062775 | European Style Taper,Press-Fit Hip Stem | Ortho Development Corp. | 2007 | 4 |
| 0 (this device) | K131022 | Ovation 10/12 Hip Stem | Ortho Development Corp. | 2013 | — |
| +1 | K133386 | Ovation Tribute Hip Stem; Ovation Narrow Hip Stem | Ortho Development Corp. | 2014 | — |
| +2 | K171249 | Entrada™ hip stem | Ortho Development Corporation | 2017 | — |
| +3 | K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024 | — |
| +4 | K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025 | — |
| +1 | K132697 | Encompass 10/12 Hip Stem | Ortho Development Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 9 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 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 24.2 · 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, Class 11device Device Product Code: LPH Predicate Devices: OvationO Hip Stem, Ortho Development (K062775) TaperlocO Hip Stem, Biomet Orthopedics (K043537) Anthology… | 2007 |
| * | K043537 | Taperloc 12/14 Taper Femoral ComponentsSummary page 1…LPH Predicate Devices: OvationO Hip Stem, Ortho Development (K062775) TaperlocO Hip Stem, Biomet Orthopedics (K043537) AnthologyO Hip Stem, Smith & Nephew (1(052792) Titanium Tr… | 2005 |
| * | K052792 | Anthology Hip StemSummary page 1…t (K062775) TaperlocO Hip Stem, Biomet Orthopedics (K043537) AnthologyO Hip Stem, Smith & Nephew (1(052792) Titanium Tri-LockO Hip Stem, DePuy Orthopedics (1(010367) 5.1. Device Description:… | 2005 |
| * | K010367 | Modification to Titanium Tri-Lock Hips StemSummary page 1…7) AnthologyO Hip Stem, Smith & Nephew (1(052792) Titanium Tri-LockO Hip Stem, DePuy Orthopedics (1(010367) 5.1. Device Description: The Ovation 10/12 Hip Stem is a one-piece press-fit tapered femoral stem, designed for sin… | 2001 |
What descends from it? (5)
2 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)
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 16 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 39 ancestors have a recall of any class.
- Of its descendants, K133386 (Ortho Development Corp., 2014) has gone furthest, with 3 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. 2013, 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?
The Ovation 10/12 Hip Stem is indicated for use in uncemented total hip arthroplasty procedures in cases of:
1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia 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/K131022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131022: Ovation 10/12 Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131022
Report an extraction error
Are you the manufacturer?
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