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 · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Mar 9, 2012 as substantially equivalent to K070369 (Biomet, Inc., 2007) and 7 other predicates after a 164-day review. Its family tree reaches back 7 generations to 1994. 53 later devices descend from it.
- Decided
- Mar 9, 2012
- Review
- 164 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 7 generations to K931641 (1994). 65 ancestors in all, the oldest K810258 (1981). 53 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 5 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 4 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 3 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 2 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 1 generation backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- This deviceK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- Descendant · cites it directly · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- Descendant · 2 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- Descendant · 3 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · cites it directly · 17 of its ownK162719 iTotal® Hip Replacement SystemConformis, Inc. · 2017 · Recalled
- Descendant · cites it directly · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · cites it directly21descendants
- K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · 2 generations on20descendants
- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 3 generations on19descendants
- K162719iTotal® Hip Replacement SystemConformis, Inc. · 2017 · cites it directly17descendants
- K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −6 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −5 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −4 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −3 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −2 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −1 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| 0 (this device) | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| +1 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| +2 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| +3 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +1 | K162719 | iTotal® Hip Replacement System | Conformis, Inc. | 2017 | 4 |
| +1 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
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 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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 OQG? 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 OQG device
- #1 K200328 Tesera Trabecular Technologies (T3) Acetabular…score 4.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K070369 | Regenerx Ringloc + Modular Acetabular ShellsSummary page 1…ent to the following hip systems or components: System Components Predicates Acetabular Shells - Porous Biomet Regenerex Ringloc Plus - K070369 Structured ______________________ ____ Acetabular Shells - Beaded Surface… | 2007 |
| * | K060635 | Consensus Acetabular Shell SystemSummary page 1…369 Structured ______________________ ____ Acetabular Shells - Beaded Surface Consensus Acetabular Shells - K(060635 Page 1 Acetabular Liners - highly StelKast Exp Acetabu… | 2006 |
| * | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMSummary page 2…cetabular Shells - K(060635 Page 1 Acetabular Liners - highly StelKast Exp Acetabular Liners - K094035 crosslinked Vitamin Epolyethylene Acetabular Liners - standard Stryker Trident Acetabular Shell System - K010170 polye… | 2011 |
| * | K010170 | Trident Porous Titanium Acetabular ComponentSummary page 2…StelKast Exp Acetabular Liners - K094035 crosslinked Vitamin Epolyethylene Acetabular Liners - standard Stryker Trident Acetabular Shell System - K010170 polyethylene Bone Screws and Dome Hole Biomet: Regenerex Ringloc Plus Acetabular Shell System Occluder… | 2001 |
| * | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Summary page 2…-K1070369 Femoral Stems and CoCr Heads Exactech AcuMatch P-Series Hip Stems - plasma sprayed - K102487, K042842, K041906 Or Smith & Nephew Anthology Plasma Sprayed Hip Stems -… | 2010 |
| * | K042842 | Novation 12/14 Press-Fit Femoral StemSummary page 2…-K1070369 Femoral Stems and CoCr Heads Exactech AcuMatch P-Series Hip Stems - plasma sprayed - K102487, K042842, K041906 Or Smith & Nephew Anthology Plasma Sprayed Hip Stems -… | 2004 |
| * | K041906 | Exactech 12/14 Total Hip SystemSummary page 2…-K1070369 Femoral Stems and CoCr Heads Exactech AcuMatch P-Series Hip Stems - plasma sprayed - K102487, K042842, K041906 Or Smith & Nephew Anthology Plasma Sprayed Hip Stems -… | 2004 |
| * | K052792 | Anthology Hip StemSummary page 2…prayed - K102487, K042842, K041906 Or Smith & Nephew Anthology Plasma Sprayed Hip Stems - K052792 Device Description The Pipeline Total Hip System is an artificial hip replacement system comprised of femoral stems and mating… | 2005 |
What descends from it? (53)
See all 536 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122158 | PBP Total Hip System | 2012 | 21 |
| K162719 | iTotal® Hip Replacement System | 2017 | 17 |
| K141972 | Klassic HD Acetabular Insert with E-Link Poly | 2014 | 14 |
| K130353 | Pipeline Total Hip System (Line Extension) | 2013 | 1 |
| K142606 | Trident® Tritanium® PST® Acetabular Shells | 2015 | 0 |
| K130652 | Vitalite E Cross-Linked Polyethylene Acetabular Insert | 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 18 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 65 ancestors have a recall of any class.
- Of its descendants, K122158 (Pipeline Biomedical Products, LLC, 2012) has gone furthest, with 21 descendants of its own.
- 4 other devices also cite its predicate K070369.
How does its category compare?
All OQG devicesOQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OQG
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OQG
99in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQG
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQG
16in 2025
MAUDE reports naming product code OQG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 144 | 0 | 0 |
| 2013 | 3 | 280 | 1 | 5 |
| 2014 | 3 | 99 | 0 | 31 |
| 2015 | 1 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 3 | 99 | 0 | 27 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 104 |
| 2020 | 2 | — | 0 | 178 |
| 2021 | 2 | — | 0 | 88 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
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, hemniarthroplasty, surface replacement arthroplasty or total hip replacement.
The Pipeline Total Hip System is intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112802: 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/K112802
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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