510(k) · Cleared
ClearedPipeline Total Hip System (Line Extension)
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 Jul 1, 2013 as substantially equivalent to K112802 (Pipeline Orthopedics, 2012) and 2 other predicates after a 139-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Jul 1, 2013
- Review
- 139 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K931641 (1994). 73 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 6 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 5 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 4 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 3 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 2 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 1 generation backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- This deviceK130353 Pipeline Total Hip System (Line Extension)Pipeline Orthopedics · 2013
- Descendant · cites it directly · 0 of its ownK132626 Pipeline Total Hip System (Line Extension)Pipeline Biotechnology · 2013
Most influential descendants
Showing 1 of 1 · See all- K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −7 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −6 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −5 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −4 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −3 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −2 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −1 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| 0 (this device) | K130353 | Pipeline Total Hip System (Line Extension) | Pipeline Orthopedics | 2013 | — |
| +1 | K132626 | Pipeline Total Hip System (Line Extension) | Pipeline Biotechnology | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112802 | Pipeline Total Hip SystemSummary page 1…Clearance Number Date Pipeline Total Hip System Pipeline Orthopedics K1 12802 3/9/2012 PBP Total Hip System Pipeline Biomedical Products K122802 12/11/2012 Synergy Hip System… | 2012 |
| Kept off the family tree | K122802 | PBP Total Hip System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Date Pipeline Total Hip System Pipeline Orthopedics K1 12802 3/9/2012 PBP Total Hip System Pipeline Biomedical Products K122802 12/11/2012 Synergy Hip System Smith & Nephew Orthopedics K061 066 7/14/2006 Trident Screw Hole… | |
| * | K061066 | Synergy Hip SystemSummary page 1…/9/2012 PBP Total Hip System Pipeline Biomedical Products K122802 12/11/2012 Synergy Hip System Smith & Nephew Orthopedics K061 066 7/14/2006 Trident Screw Hole Plugs Stryker Orthopaedics (formerly K022799 11/21/2002 ____________… | 2006 |
| * | K022799 | Trident Screw Hole Plug and Trident Bone SpikeSummary page 1…/11/2012 Synergy Hip System Smith & Nephew Orthopedics K061 066 7/14/2006 Trident Screw Hole Plugs Stryker Orthopaedics (formerly K022799 11/21/2002 ____________________ Howmedica Osteonics Corp.) _ ___________… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132626 | Pipeline Total Hip System (Line Extension) | 2013 | 0 |
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 4 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 73 ancestors have a recall of any class.
- Of its descendants, K132626 (Pipeline Biotechnology, 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K112802.
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?
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 dlysplasia; Acute traumatic fracture of the femoral head or neck; Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty…
Read the full statement (116 words)
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 dlysplasia;
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 PIPELINE Tapered Femoral Stem and PIPELINE PSTTM Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
The PIPELINE PSTTM Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130353: Pipeline Total Hip System (Line Extension).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130353
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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