510(k) · Cleared
ClearedTitan Porocoat Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 25, 2000 as substantially equivalent to K974331 (Johnson & Johnson Professionals, Inc., 1998) and 2 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1994. 188 later devices descend from it.
- Decided
- Aug 25, 2000
- Review
- 57 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935452 (1994). 13 ancestors in all, the oldest K851422 (1985). 188 later devices descend from it, 10 citing it directly.
- Root · 4 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 3 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 2 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 1 generation backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- This deviceK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- Descendant · cites it directly · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 71 of its ownK082525 Corin Metafix Femoral StemCorin USA · 2010 · Recalled
- Descendant · 3 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 2 generations on · 49 of its ownK070554 Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc. · 2007
- Descendant · 2 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
Showing 5 of 188 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 188 · See all- K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · cites it directly168descendants
- K082525Corin Metafix Femoral StemCorin USA · 2010 · 2 generations on71descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 3 generations on61descendants
- K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc. · 2007 · 2 generations on49descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 2 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −3 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −2 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −1 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| 0 (this device) | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| +1 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| +2 | K082525 | Corin Metafix Femoral Stem | Corin USA | 2010 | 2 |
| +3 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +2 | K070554 | Depuy Corail Amt Dysplasia Hip Prosthesis | DePuy Orthopaedics, Inc. | 2007 | — |
| +2 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 10 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 9 | 0 |
| 2017 | 12 | 0 |
| 2018 | 12 | 0 |
| 2019 | 14 | 0 |
| 2020 | 15 | 0 |
| 2021 | 9 | 0 |
| 2022 | 15 | 0 |
| 2023 | 19 | 0 |
| 2024 | 15 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | K974331 | Uni-Rom Total Hip System Femoral StemSummary page 1…n 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems. Substantially Equivalent Device: UNI-ROM FemoralHip Stem K974331 Stability HipFemoral… | 1998 |
| * | K934457 | Stability Hip Stem with PorocoatSummary page 1…K974331 Stability HipFemoral Component K934457 withPorocoat VisionAML HipProsthesis K953694 DeviceDescr… | 1994 |
| * | K953694 | Depuy Vision Aml Hip ProthesisSummary page 1…Component K934457 withPorocoat VisionAML HipProsthesis K953694 DeviceDescriptions: The TitanPorousHip isa collarless, titanium, tapered,pres… | 1996 |
What descends from it? (188)
See all 18810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042992 | Corail Amt Hip Prosthesis | 2005 | 168 |
| K011489 | Summit Duofix Hip Prosthesis | 2001 | 40 |
| K170339 | Summit Hip System | 2018 | 27 |
| K042959 | Depuy C-Stem Amt Hip Prosthesis | 2004 | 23 |
| K193398 | Summit DuoFix HA Coating | 2020 | 20 |
| K033893 | Spectrum Modular System | 2004 | 8 |
| K211657 | EMPHASYS Femoral Stems | 2021 | 7 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 | 5 |
| K163585 | Responsive Orthopedics Total Hip Arthroplasty System | 2017 | 1 |
| K191826 | KeYi Total Hip System | 2020 | 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 6 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K042992 (DePuy Orthopaedics, Inc., 2005) has gone furthest, with 168 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.
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?
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis…
Read the full statement (123 words)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The Titan Porocoat Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
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/K001991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001991: Titan Porocoat Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001991
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026