510(k) · Cleared
ClearediNSitu Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Companies, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 14, 2016 as substantially equivalent to K131237 (Pipeline Orthopedics, 2013) and 2 other predicates after a 170-day review. Its family tree reaches back 10 generations to 1994. 19 later devices descend from it.
- Decided
- Oct 14, 2016
- Review
- 170 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K931641 (1994). 189 ancestors in all, the oldest K810258 (1981). 19 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations between
- 3 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 2 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- 1 generation backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- This deviceK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · cites it directly · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · cites it directly · 7 of its ownK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- Descendant · 2 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · 2 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- Descendant · cites it directly · 4 of its ownK192071 iNSitu Total Hip SystemTheken Companies, LLC · 2019
Show all 10 generations
- Root · 10 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 8 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 7 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 6 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 5 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 4 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 3 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 2 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- 1 generation backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- This deviceK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · cites it directly9descendants
- K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017 · cites it directly7descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 2 generations on5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 2 generations on4descendants
- K192071iNSitu Total Hip SystemTheken Companies, LLC · 2019 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −9 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −8 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −7 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −6 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −5 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −4 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −3 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −2 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| −1 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| 0 (this device) | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +1 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +1 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
| +2 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +2 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| +1 | K192071 | iNSitu Total Hip System | Theken Companies, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 25 | 0 |
| 1995 | 18 | 0 |
| 1996 | 16 | 0 |
| 1997 | 13 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 14 | 0 |
| 2001 | 6 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K131237 | Pipeline Total Hip SystemSummary page 5…510(k) Number(s) Clearance Date Restoris Stem and Pipeline K131237 6/13/2013 Restoris PST Cup TaperSet Stem an… | 2013 |
| * | K121935 | Taperset Hip Small StemsSummary page 5…K131237 6/13/2013 Restoris PST Cup TaperSet Stem and CS2 K121935, 9/10/2012, Consensus Cup K141043… | 2012 |
| * | K141043 | CS2 Multi-Hole Acetabular ShellSummary page 5…TaperSet Stem and CS2 K121935, 9/10/2012, Consensus Cup K141043 5/19/2014 Device Description The iNSitu Total Hip Replacement System is an artificial hip replacement system. Th… | 2014 |
What descends from it? (19)
See all 197 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163577 | Ecofit® Hip System | 2017 | 9 |
| K172501 | iNSitu Total Hip System | 2017 | 7 |
| K192071 | iNSitu Total Hip System | 2019 | 4 |
| K191936 | iNSitu Total Hip System | 2019 | 2 |
| K241875 | TheRay Collared and Collarless Femoral Stem | 2024 | 1 |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi… | 2026 | 0 |
| K220336 | Mg-PSZ Ceramic Femoral Head | 2022 | 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 22 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 39 of the 188 ancestors have a recall of any class.
- Of its descendants, K163577 (Implantcast GmbH, 2017) has gone furthest, with 9 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. 2016, 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 iNSitu 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 (101 words)
The iNSitu 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 iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.
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/K161184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161184: iNSitu 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/K161184
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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