510(k) · Cleared
ClearedPBP Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pipeline Biomedical Products, LLC · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Dec 11, 2012 as substantially equivalent to K112802 (Pipeline Orthopedics, 2012) and 3 other predicates after a 144-day review. Its family tree reaches back 8 generations to 1994. 21 later devices descend from it.
- Decided
- Dec 11, 2012
- Review
- 144 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K931641 (1994). 146 ancestors in all, the oldest K810258 (1981). 21 later devices descend 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 deviceK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- Descendant · cites it directly · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- Descendant · 2 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · 3 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · 3 generations on · 7 of its ownK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- Descendant · 4 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · cites it directly20descendants
- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 2 generations on19descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 3 generations on9descendants
- K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017 · 3 generations on7descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 4 generations on5descendants
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) | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| +1 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| +2 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +3 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +3 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
| +4 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K112802 | Pipeline Total Hip SystemSummary page 2…earance Date Pipeline Total Hip System Pipeline Orthopedics K112802 3/9/2012 Tritaniumg Peri-Apatite Acetabular Shell Howmedica Osteonics K101072 4/11/2011 System… | 2012 |
| * | K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteSummary page 2…Date Pipeline Total Hip System Pipeline Orthopedics K112802 3/9/2012 Tritaniumg Peri-Apatite Acetabular Shell Howmedica Osteonics K101072 4/11/2011 System K971206 2/11/1998 Biolox delta Cerami… | 2011 |
| * | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite CoatingSummary page 2…/2012 Tritaniumg Peri-Apatite Acetabular Shell Howmedica Osteonics K101072 4/11/2011 System K971206 2/11/1998 Biolox delta Ceramic Femoral Head Zimmer K071535 11/19/2007 S. Device Descri… | 1998 |
| * | K071535 | Biolox Delta Ceramic Femoral HeadSummary page 2…/2011 System K971206 2/11/1998 Biolox delta Ceramic Femoral Head Zimmer K071535 11/19/2007 S. Device Description The PBP Total Hip System is an artificial hip replacement system. The system includes fe… | 2007 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131237 | Pipeline Total Hip System | 2013 | 20 |
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 5 companies; a new generation was cleared every 1.3 years on median.
- 37 of the 145 ancestors have a recall of any class.
- Of its descendants, K131237 (Pipeline Orthopedics, 2013) has gone furthest, with 20 descendants of its own.
- 5 other devices also cite its predicate K112802.
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?
The PBP 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…
Read the full statement (124 words)
The PBP 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 PBP Total Hip System hip stems and porous structured acetabular shells are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
The PBP Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122158: PBP 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/K122158
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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