510(k) · Cleared
ClearedUTF Stem, reduced, #0, #00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 8, 2017 as substantially equivalent to K123550 (United Orthopedic Corporation, 2013) and 2 other predicates after a 205-day review. Its family tree reaches back 7 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 8, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to P960047 (1997). 29 ancestors in all, the oldest K830313 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 6 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
- 5 generations backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
- 4 generations backK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- 3 generations backK110245 United Utf StemUnited Orthopedic Corporation · 2011 · Recalled
- 2 generations backK123550 Utf Stem, ReducedUnited Orthopedic Corporation · 2013
- 1 generation backK132207 Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation · 2013
- This deviceK163193 UTF Stem, reduced, #0, #00United Orthopedic Corporation · 2017
- Descendant · cites it directly · 1 of its ownK172251 UTS StemUnited Orthopedic Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK242315 Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −6 | K021728 | Ringloc Constrained Liners II | Biomet, Inc. | 2002 | — |
| −5 | K030047 | Freedom Constrained Liners | Biomet, Inc. | 2003 | — |
| −4 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| −3 | K110245 | United Utf Stem | United Orthopedic Corporation | 2011 | 1 |
| −2 | K123550 | Utf Stem, Reduced | United Orthopedic Corporation | 2013 | — |
| −1 | K132207 | Utf Stem-Reduced, Additional Sizes | United Orthopedic Corporation | 2013 | — |
| 0 (this device) | K163193 | UTF Stem, reduced, #0, #00 | United Orthopedic Corporation | 2017 | — |
| +1 | K172251 | UTS Stem | United Orthopedic Corporation | 2017 | — |
| +2 | K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K123550 | Utf Stem, ReducedSummary page 4…Panel. Device Class Class II Classification Panel Orthopaedics Product Code LPH, KWY, LZO Predicate Device 1. “UNITED” UTF Stem, Reduced (K123550) 2. “UNITED” UTF Stem-reduced, Additional Sizes (K132207)… | 2013 |
| * | K132207 | Utf Stem-Reduced, Additional SizesSummary page 4…KWY, LZO Predicate Device 1. “UNITED” UTF Stem, Reduced (K123550) 2. “UNITED” UTF Stem-reduced, Additional Sizes (K132207) 3. “UNITED” UTF Stem (K110245)… | 2013 |
| * | K110245 | United Utf StemSummary page 4…Reduced (K123550) 2. “UNITED” UTF Stem-reduced, Additional Sizes (K132207) 3. “UNITED” UTF Stem (K110245) K163193… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172251 | UTS Stem | 2017 | 1 |
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 20 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K172251 (United Orthopedic Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K123550.
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. 2017, 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?
This device is indicated for use in total hip replacement or bipolar hip replacement undergoing primary and revision surgery for the following conditions:
1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
2. Inflammatory degenerative joint disease such as rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision procedures where other treatments or devices have failed.
This device is designed for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163193 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163193: UTF Stem, reduced, #0, #00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163193
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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