510(k) · Cleared
ClearedUni-Rom Total Hip System Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 6, 1998 as substantially equivalent to K961939 (Johnson & Johnson Professionals, Inc., 1996) and 4 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1994. 189 later devices descend from it.
- Decided
- Feb 6, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K935452 (1994). 9 ancestors in all, the oldest K851422 (1985). 189 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 2 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 1 generation backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- This deviceK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- Descendant · cites it directly · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 71 of its ownK082525 Corin Metafix Femoral StemCorin USA · 2010 · Recalled
- Descendant · 4 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
- Descendant · 3 generations on · 49 of its ownK070554 Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc. · 2007
Showing 5 of 189 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 189 · See all- K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · cites it directly188descendants
- K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 2 generations on168descendants
- K082525Corin Metafix Femoral StemCorin USA · 2010 · 3 generations on71descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 4 generations on61descendants
- K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc. · 2007 · 3 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −2 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −1 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| 0 (this device) | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| +1 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| +3 | K082525 | Corin Metafix Femoral Stem | Corin USA | 2010 | 2 |
| +4 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
| +3 | K070554 | Depuy Corail Amt Dysplasia Hip Prosthesis | DePuy Orthopaedics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Summary page 1…tantiaily equivalent in terms of intended use, materials, design, manufacturing processes, sterilization method, packaging and performance to the S-ROM Femoral Hip Stem (K961939, K954935 and K851422) and P.F.C. 2 Femoral Stem (K945518 and K935452). 4, Indications for Use: The UNI-ROM™ Total Hip Stem is i… | 1996 |
| * | K954935 | S-Rom Femoral Hip Stem - Size 14 X 8Summary page 1…equivalent in terms of intended use, materials, design, manufacturing processes, sterilization method, packaging and performance to the S-ROM Femoral Hip Stem (K961939, K954935 and K851422) and P.F.C. 2 Femoral Stem (K945518 and K935452). 4, Indications for Use: The UNI-ROM™ Total Hip Stem is indicated… | 1996 |
| * | K851422 | S-Rom 135 Femoral Stem & Collar (Part of S-Rom HipSummary page 1…in terms of intended use, materials, design, manufacturing processes, sterilization method, packaging and performance to the S-ROM Femoral Hip Stem (K961939, K954935 and K851422) and P.F.C. 2 Femoral Stem (K945518 and K935452). 4, Indications for Use: The UNI-ROM™ Total Hip Stem is indicated for use in t… | 1985 |
| * | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentSummary page 1…design, manufacturing processes, sterilization method, packaging and performance to the S-ROM Femoral Hip Stem (K961939, K954935 and K851422) and P.F.C. 2 Femoral Stem (K945518 and K935452). 4, Indications for Use: The UNI-ROM™ Total Hip Stem is indicated for use in total hip replacement procedures for… | 1996 |
| * | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentSummary page 1…ufacturing processes, sterilization method, packaging and performance to the S-ROM Femoral Hip Stem (K961939, K954935 and K851422) and P.F.C. 2 Femoral Stem (K945518 and K935452). 4, Indications for Use: The UNI-ROM™ Total Hip Stem is indicated for use in total hip replacement procedures for patients suf… | 1994 |
What descends from it? (189)
See all 1891 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K001991 | Titan Porocoat Hip Prosthesis | 2000 | 188 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K001991 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 188 descendants of its own.
- 8 other devices also cite its predicate K961939.
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?
The UNI-ROM™ Total Hip System Femoral Stem is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
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/K974331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974331: Uni-Rom Total Hip System Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974331
Report an extraction error
Are you the manufacturer?
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