510(k) · Cleared
ClearedEncompass 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 Jun 20, 2014 as substantially equivalent to K053293 (Ortho Development Corp., 2006) and 3 other predicates after a 295-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jun 20, 2014
- Review
- 295 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to P960047 (1997). 42 ancestors in all, the oldest K830313 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 5 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
- 4 generations backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
- 3 generations backK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- 2 generations backK062775 European Style Taper,Press-Fit Hip StemOrtho Development Corp. · 2007 · Recalled
- 1 generation backK131022 Ovation 10/12 Hip StemOrtho Development Corp. · 2013
- This deviceK132697 Encompass 10/12 Hip StemOrtho Development Corp. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −5 | K021728 | Ringloc Constrained Liners II | Biomet, Inc. | 2002 | — |
| −4 | K030047 | Freedom Constrained Liners | Biomet, Inc. | 2003 | — |
| −3 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| −2 | K062775 | European Style Taper,Press-Fit Hip Stem | Ortho Development Corp. | 2007 | 4 |
| −1 | K131022 | Ovation 10/12 Hip Stem | Ortho Development Corp. | 2013 | — |
| 0 (this device) | 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 | 4 | 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 |
| 2006 | 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 |
|---|---|---|---|
| * | K053293 | Encompass 10*17 and 12*17 Extended Press-Fit Hip StemsSummary page 1…porous-coated uncemented prosthesis Device Product Code: LPH, MBL Predicate Devices: Encompass' Press-Fit Hip Stem (K053293) Ortho Development PrimalocT" Cementless Hip System (K(953977) Ortho Development… | 2006 |
| * | K953977 | Primaloc Cementless Hip SystemSummary page 1…BL Predicate Devices: Encompass' Press-Fit Hip Stem (K053293) Ortho Development PrimalocT" Cementless Hip System (K(953977) Ortho Development Ovation 10/12 Hip Stem (K(131022) Ortho Development… | 1996 |
| * | K131022 | Ovation 10/12 Hip Stem Cleared while this submission was under review Summary page 1…velopment PrimalocT" Cementless Hip System (K(953977) Ortho Development Ovation 10/12 Hip Stem (K(131022) Ortho Development Bi-Metric6 Porous Primary Femoral Component (K(020580) Biomet Device Des… | 2013 |
| * | K020580 | X-Series BI-Metric Hip Femoral ComponentsSummary page 2…milarities to the predicate devices, and a review of the testing, the devices are substantially equivalent to femoral stem components that were cleared under K053293 and K020580. DEPARTNMENT OF HEALTH1 &I HUMAAN SERVICES Public I lealil, ervice… | 2002 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 8 of the 42 ancestors have a recall of any class.
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?
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis
2. Previously failed surgery
3. Proximal femoral neck fractures or dislocation
4. Idiopathic avascular necrosis of the femoral head
5. Non-union of proximal femoral neck fractures
6. Treatment of fractures that are unmianageable 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/K132697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132697: Encompass 10/12 Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132697
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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