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 Aug 30, 2019 as substantially equivalent to K161184 (Theken Companies, LLC, 2016) and 1 other predicate after a 28-day review. Its family tree reaches back 12 generations to 1994. 4 later devices descend from it.
- Decided
- Aug 30, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K931641 (1994). 191 ancestors in all, the oldest K810258 (1981). 4 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations between
- 3 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- 2 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 1 generation backK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- This deviceK192071 iNSitu Total Hip SystemTheken Companies, LLC · 2019
- Descendant · cites it directly · 2 of its ownK241690 Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252824 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball…Signature Orthopaedics Pty, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK243162 World LinerSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK220336 Mg-PSZ Ceramic Femoral HeadTheken Companies · 2022
Show all 12 generations
- Root · 12 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 10 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 9 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 8 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 7 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 6 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 5 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 4 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- 3 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- 2 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 1 generation backK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- This deviceK192071 iNSitu Total Hip SystemTheken Companies, LLC · 2019
Most influential descendants
Showing 4 of 4 · See all- K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024 · cites it directly2descendants
- K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd. · 2026 · 2 generations on0descendants
- K243162World LinerSignature Orthopaedics Pty, Ltd. · 2024 · 2 generations on0descendants
- K220336Mg-PSZ Ceramic Femoral HeadTheken Companies · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −11 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −10 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −9 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −8 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −7 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −6 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −5 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −4 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| −3 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| −2 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| −1 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
| 0 (this device) | K192071 | iNSitu Total Hip System | Theken Companies, LLC | 2019 | — |
| +1 | K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +2 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026 | — |
| +2 | K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +1 | K220336 | Mg-PSZ Ceramic Femoral Head | Theken Companies | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 24.3 · 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? (2)
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 |
|---|---|---|---|
| * | K161184 | iNSitu Total Hip SystemSummary page 4…y Marketed Predicate This Special 510(k) submission is to add a line extension, specifically a dual-tapered (Blade) Femoral Stem, to the iNSitu Total Hip System (K161184/K172501). Company Device Name 510(k) Number(s) Clearance Date… | 2016 |
| * | K172501 | iNSitu Total Hip SystemSummary page 4…ed Predicate This Special 510(k) submission is to add a line extension, specifically a dual-tapered (Blade) Femoral Stem, to the iNSitu Total Hip System (K161184/K172501). Company Device Name 510(k) Number(s) Clearance Date… | 2017 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 39 of the 190 ancestors have a recall of any class.
- Of its descendants, K241690 (Signature Orthopaedics Pty, Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K161184.
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. 2019, 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 (104 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/K192071 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192071: iNSitu Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192071
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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