510(k) · Cleared
ClearediNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextstep Arthopedix, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 5, 2026 as substantially equivalent to K161184 (Theken Companies, LLC, 2016) and 4 other predicates after a 613-day review. Its family tree reaches back 16 generations to 1994.
- Decided
- Jun 5, 2026
- Review
- 613 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K941847 (1994). 289 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations between
- 3 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 2 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 1 generation backK241875 TheRay Collared and Collarless Femoral StemNextstep Arthropedix · 2024 · Recalled
- This deviceK243192 iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with…Nextstep Arthopedix, LLC · 2026
Show all 16 generations
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 15 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 14 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 13 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 12 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 11 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 10 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 9 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 8 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 7 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 6 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 5 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 4 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 3 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 2 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 1 generation backK241875 TheRay Collared and Collarless Femoral StemNextstep Arthropedix · 2024 · Recalled
- This deviceK243192 iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with…Nextstep Arthopedix, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −15 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −14 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −13 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −12 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −11 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −10 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −9 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −8 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −7 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −6 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −5 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −4 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −3 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −2 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −1 | K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | 2024 | 1 |
| 0 (this device) | K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed… | Nextstep Arthopedix, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 7 | 0 |
| 1993 | 7 | 0 |
| 1994 | 33 | 0 |
| 1995 | 21 | 0 |
| 1996 | 22 | 0 |
| 1997 | 12 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 24 | 0 |
| 2001 | 15 | 0 |
| 2002 | 15 | 0 |
| 2003 | 12 | 0 |
| 2004 | 9 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 9 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 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? (5)
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 6…MEH Advisory Panel: 87 (Orthopedic) Legally Marketed Predicate The iNSitu Total Hip System (K161184 / K172501 / K191936) is the primary predicate device and included for indications for use and performance comparisons. The iNSitu… | 2016 |
| * | K172501 | iNSitu Total Hip SystemSummary page 6…MEH Advisory Panel: 87 (Orthopedic) Legally Marketed Predicate The iNSitu Total Hip System (K161184 / K172501 / K191936) is the primary predicate device and included for indications for use and performance comparisons. The iNSitu Bipolar H… | 2017 |
| * | K191936 | iNSitu Total Hip SystemSummary page 6…MEH Advisory Panel: 87 (Orthopedic) Legally Marketed Predicate The iNSitu Total Hip System (K161184 / K172501 / K191936) is the primary predicate device and included for indications for use and performance comparisons. The iNSitu Bipolar Hip System… | 2019 |
| * | K191297 | iNSitu Bipolar Hip SystemSummary page 6…Hip System (K161184 / K172501 / K191936) is the primary predicate device and included for indications for use and performance comparisons. The iNSitu Bipolar Hip System (K191297) is an additional predicate. Page 1 of 3… | 2019 |
| * | K241875 | TheRay Collared and Collarless Femoral StemSummary page 7…r use to the predicates: iNSitu Total Hip System (K161184, K172501, K191936), the iNSitu Bipolar Hip System (K191297), and the TheRay Collared and Collarless Hip System (K241875). Summary of Technological Characteristics Page 2 of 3… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 63 of the 288 ancestors have a recall of any class.
- 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. 2026, 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 (281 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 stems are 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.
TheRay Collared and Collarless 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.
TheRay Collared and Collarless Total Hip System femoral stems are intended for cementless fixation. The acetabular cup is intended for cementless fixation. The porous structured surfaces on the acetabular cup provide biological fixation in a cementless application.
The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System femoral stem for cemented or uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other devices or treatments for these indications have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243192: iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243192
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026