510(k) · Cleared
ClearedPipeline Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pipeline Orthopedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 13, 2013 as substantially equivalent to K122158 (Pipeline Biomedical Products, LLC, 2012) after a 43-day review. Its family tree reaches back 9 generations to 1994. 20 later devices descend from it.
- Decided
- Jun 13, 2013
- Review
- 43 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931641 (1994). 147 ancestors in all, the oldest K810258 (1981). 20 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations between
- 3 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 2 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 1 generation backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- This deviceK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- Descendant · cites it directly · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · 2 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- Descendant · 3 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · 3 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
Show all 9 generations
- Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 7 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 6 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 5 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 4 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 3 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 2 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 1 generation backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- This deviceK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · cites it directly19descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 2 generations on9descendants
- K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017 · 2 generations on7descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 3 generations on5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −8 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −7 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −6 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −5 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −4 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −3 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −2 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −1 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| 0 (this device) | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| +1 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +2 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +2 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
| +3 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +3 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 5 | 0 |
| 1994 | 22 | 0 |
| 1995 | 15 | 0 |
| 1996 | 9 | 0 |
| 1997 | 10 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 12 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2026 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K122158 | PBP Total Hip SystemSummary page 1…ion to the Pipeline Total Hip System (510(k) #K112802), and introduces hip system components that have already been determined substantially equivalent by FDA in 510(k} #K122158 for the designated indications for use under the name of the holding company’s other subsidiary. Page 11 of 29 K… | 2012 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161184 | iNSitu Total Hip System | 2016 | 19 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 37 of the 146 ancestors have a recall of any class.
- Of its descendants, K161184 (Theken Companies, LLC, 2016) has gone furthest, with 19 descendants of its own.
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 Pipeline Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: * A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia. * Acute traumatic fracture of the femoral head or neck. * Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis…
Read the full statement (121 words)
The Pipeline Total Hip System is indicated for use in skeletally mature individuals
undergoing surgery for total hip replacement due to:
* A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
* Acute traumatic fracture of the femoral head or neck.
* Failed previous hip surgery including joint reconstruction, internal fixation,
arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip
replacement.
The Tapered Hip Stem and PST™ Acetabular Shell are intended for cementless or
cemented fixation. The porous structured (PST™) surface provides biological fixation
when used in a cementless application.
The Pipeline Total Hip System HA porous structured acetabular shells are intended for
cementless fixation. The HA porous structured surface provides biological fixation.
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/K131237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131237: Pipeline Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131237
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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