510(k) · Cleared
ClearedMg-PSZ Ceramic Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Companies · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Sep 30, 2022 as substantially equivalent to K161184 (Theken Companies, LLC, 2016) and 5 other predicates after a 235-day review. Its family tree reaches back 13 generations to 1994.
- Decided
- Sep 30, 2022
- Review
- 235 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K931641 (1994). 195 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 13 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations between
- 3 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 2 generations backK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- 1 generation backK191936 iNSitu Total Hip SystemThecken Companies, LLC · 2019
- This deviceK220336 Mg-PSZ Ceramic Femoral HeadTheken Companies · 2022
Show all 13 generations
- Root · 13 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 11 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 10 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 9 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 8 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 7 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 6 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 5 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- 4 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- 3 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 2 generations backK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- 1 generation backK191936 iNSitu Total Hip SystemThecken Companies, LLC · 2019
- This deviceK220336 Mg-PSZ Ceramic Femoral HeadTheken Companies · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −12 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −11 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −10 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −9 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −8 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −7 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −6 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −5 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| −4 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| −3 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| −2 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
| −1 | K191936 | iNSitu Total Hip System | Thecken Companies, LLC | 2019 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 26 | 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 |
| 2019 | 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 24.2 · 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? (6)
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…al Head Primary predicate device: NextStep Arthropedix Biolox Delta ceramic femoral head, K161184 Additional predicate devices: BioPro Ziralloy modular ceramic femoral head, K912641,… | 2016 |
| * | K912641 | Biopro Ziralloy Modular Femoral HeadsSummary page 4…ral head, K161184 Additional predicate devices: BioPro Ziralloy modular ceramic femoral head, K912641, K925682 NextStep Arthr… | 1991 |
| * | K925682 | Biopro Ziralloy Modular Femoral Heads, ModifiedSummary page 4…K161184 Additional predicate devices: BioPro Ziralloy modular ceramic femoral head, K912641, K925682 NextStep Arthropedix Biolox Delta ceramic femoral… | 1994 |
| * | K172501 | iNSitu Total Hip SystemSummary page 4…K925682 NextStep Arthropedix Biolox Delta ceramic femoral head, K172501, K192071, K191936 Regulation Number and Description: 21 CFR 888.3358… | 2017 |
| * | K192071 | iNSitu Total Hip SystemSummary page 4…NextStep Arthropedix Biolox Delta ceramic femoral head, K172501, K192071, K191936 Regulation Number and Description: 21 CFR 888.3358… | 2019 |
| * | K191936 | iNSitu Total Hip SystemSummary page 4…NextStep Arthropedix Biolox Delta ceramic femoral head, K172501, K192071, K191936 Regulation Number and Description: 21 CFR 888.3358 21 CFR… | 2019 |
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 28 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 40 of the 194 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. 2022, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220336: Mg-PSZ Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220336
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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