510(k) Report

510(k) · Cleared

Cleared

Resolve Modular Revision Hip Stem

K242315510(k) TraditionalCleared May 1, 2025269-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

United Orthopedic Corporation · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on May 1, 2025 as substantially equivalent to K090757 (Biomet, Inc., 2009) and 9 other predicates after a 269-day review. Its family tree reaches back 9 generations to 1997.

Decided
May 1, 2025
Review
269 days
Class
Class II
Product code
MEH
Recalls
None
Predicates
10

Its longest line of descent runs back 9 generations to P960047 (1997). 81 ancestors in all, the oldest K830313 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2021: 1 other ancestor2019: 1 other ancestor2009: 1 other ancestor2005: 5 other ancestors2002: 3 other ancestors2001: 2 other ancestors2000: 7 other ancestors2012: 1 other ancestor2008: 1 other ancestor2003: 2 other ancestors1999: 3 other ancestors1996: 12 other ancestors1994: 12 other ancestors1998: 3 other ancestors1997: 4 other ancestors1995: 6 other ancestors1983: 1 other ancestor1993: 1 other ancestor1986: 1 other ancestor1985: 2 other ancestors1992: 2 other ancestors1991: 1 other ancestorP960047 · Osteonics Constrained Acetabular Insert · Howmedica Osteonics Corp. · 1997×2: 2 generations cleared close together, K021728 (2002), K030047 (2003) K043537 · Taperloc 12/14 Taper Femoral Components · Biomet, Inc. · 2005K110245 · United Utf Stem · United Orthopedic Corporation · 2011 · recalled×2: 2 generations cleared close together, K123550 (2013), K132207 (2013) ×2: 2 generations cleared close together, K163193 (2017), K172251 (2017) 19801990200020102020
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 11 other ancestors3 generations back: 16 other ancestors4 generations back: 16 other ancestors5 generations back: 17 other ancestors6 generations back: 4 other ancestors K172251 · UTS Stem · United Orthopedic Corporation · 2017K163193 · UTF Stem, reduced, #0, #00 · United Orthopedic Corporation · 2017K132207 · Utf Stem-Reduced, Additional Sizes · United Orthopedic Corporation · 2013K123550 · Utf Stem, Reduced · United Orthopedic Corporation · 2013K110245 · United Utf Stem · United Orthopedic Corporation · 2011 · recalledK043537 · Taperloc 12/14 Taper Femoral Components · Biomet, Inc. · 2005K030047 · Freedom Constrained Liners · Biomet, Inc. · 2003K021728 · Ringloc Constrained Liners II · Biomet, Inc. · 2002P960047 · Osteonics Constrained Acetabular Insert · Howmedica Osteonics Corp. · 1997−50
  1. Root · 9 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
  2. 5 generations between
  3. 3 generations backK132207 Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation · 2013
  4. 2 generations backK163193 UTF Stem, reduced, #0, #00United Orthopedic Corporation · 2017
  5. 1 generation backK172251 UTS StemUnited Orthopedic Corporation · 2017
  6. This deviceK242315 Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025
Show all 9 generations
  1. Root · 9 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
  2. 8 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
  3. 7 generations backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
  4. 6 generations backK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
  5. 5 generations backK110245 United Utf StemUnited Orthopedic Corporation · 2011 · Recalled
  6. 4 generations backK123550 Utf Stem, ReducedUnited Orthopedic Corporation · 2013
  7. 3 generations backK132207 Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation · 2013
  8. 2 generations backK163193 UTF Stem, reduced, #0, #00United Orthopedic Corporation · 2017
  9. 1 generation backK172251 UTS StemUnited Orthopedic Corporation · 2017
  10. This deviceK242315 Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9P960047Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp.1997—
−8K021728Ringloc Constrained Liners IIBiomet, Inc.2002—
−7K030047Freedom Constrained LinersBiomet, Inc.2003—
−6K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005—
−5K110245United Utf StemUnited Orthopedic Corporation20111
−4K123550Utf Stem, ReducedUnited Orthopedic Corporation2013—
−3K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation2013—
−2K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation2017—
−1K172251UTS StemUnited Orthopedic Corporation2017—
0 (this device)K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198520
198610
199110
199220
199310
1994120
199560
1996120
199740
199830
199930
200070
200120
200230
200320
200550
200810
200910
201210
201910
202110
FIG. 1 — Lineage of K242315, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MEH? 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 MEH device

  1. #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090757Biomet Modular Femoral Revision System
Summary page 5
…Regulation Number 888.3390 Product Codes MEH, LZO, KWY Predicate Device Information 510(k) Number Predicate Trade Name K090757 Arcos® Modular Femoral Revision System K022549, Restoration® Modular System K051363, K213129 K994126…
Biomet, Inc.200918
*K022549Restoration Modular System
Summary page 5
…Product Codes MEH, LZO, KWY Predicate Device Information 510(k) Number Predicate Trade Name K090757 Arcos® Modular Femoral Revision System K022549, Restoration® Modular System K051363, K213129 K994126 MODULAR-PLUS REVISION STEM K003237 U2 Hip…
Howmedica Osteonics Corp.20023
*K051363Restoration Modular System
Summary page 5
…redicate Device Information 510(k) Number Predicate Trade Name K090757 Arcos® Modular Femoral Revision System K022549, Restoration® Modular System K051363, K213129 K994126 MODULAR-PLUS REVISION STEM K003237 U2 Hip Stem, HA/Ti plasma spray K172251 UTS…
Howmedica Osteonics Corp.2005—
*K213129Restoration Modular 115mm Conical Distal Stem
Summary page 5
…evice Information 510(k) Number Predicate Trade Name K090757 Arcos® Modular Femoral Revision System K022549, Restoration® Modular System K051363, K213129 K994126 MODULAR-PLUS REVISION STEM K003237 U2 Hip Stem, HA/Ti plasma spray K172251 UTS Stem, Ti…
Howmedica Osteonics Corp., Dba Stryker Orthopaedics2021—
*K994126Modular-Plus Revision Stem
Summary page 5
…ormation 510(k) Number Predicate Trade Name K090757 Arcos® Modular Femoral Revision System K022549, Restoration® Modular System K051363, K213129 K994126 MODULAR-PLUS REVISION STEM K003237 U2 Hip Stem, HA/Ti plasma spray K172251 UTS Stem, Ti plasma sp…
Plus Orthopedics2000—
*K003237U2 Hip Stem, TI Porous Coated
Summary page 5
…K090757 Arcos® Modular Femoral Revision System K022549, Restoration® Modular System K051363, K213129 K994126 MODULAR-PLUS REVISION STEM K003237 U2 Hip Stem, HA/Ti plasma spray K172251 UTS Stem, Ti plasma spray K050262 U2 Acetabular Component…
United Orthopedic Corp.2001—
*K172251UTS Stem
Summary page 5
…ystem K022549, Restoration® Modular System K051363, K213129 K994126 MODULAR-PLUS REVISION STEM K003237 U2 Hip Stem, HA/Ti plasma spray K172251 UTS Stem, Ti plasma spray K050262 U2 Acetabular Component K110245 UTF Stem K183312 Con…
United Orthopedic Corporation2017—
*K050262U2 Acetabular Component
Summary page 5
…System K051363, K213129 K994126 MODULAR-PLUS REVISION STEM K003237 U2 Hip Stem, HA/Ti plasma spray K172251 UTS Stem, Ti plasma spray K050262 U2 Acetabular Component K110245 UTF Stem K183312 Conformity Stem Device Resolve…
United Orthopedic Corp.2005—
*K110245United Utf Stem
Summary page 5
…MODULAR-PLUS REVISION STEM K003237 U2 Hip Stem, HA/Ti plasma spray K172251 UTS Stem, Ti plasma spray K050262 U2 Acetabular Component K110245 UTF Stem K183312 Conformity Stem Device Resolve Modular Revision Hip Stem is a modular stem…
United Orthopedic Corporation20111
*K183312Conformity Stem
Summary page 5
…M K003237 U2 Hip Stem, HA/Ti plasma spray K172251 UTS Stem, Ti plasma spray K050262 U2 Acetabular Component K110245 UTF Stem K183312 Conformity Stem Device Resolve Modular Revision Hip Stem is a modular stem optimized for Description…
United Orthopedic Corporation2019—

Also cleared against K090757: 6 other devices →

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 3 companies; a new generation was cleared every 2.0 years on median.
  • 19 of the 81 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K090757.

How does its category compare?

All MEH devices

MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · MEH

5in 2025

2007: 22008: 62009: 62010: 52011: 52012: 62013: 12015: 22016: 62017: 32018: 22019: 12020: 32021: 32022: 32023: 22024: 62025: 52026 (partial year): 1
2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2008: 79 days median2009: 65 days median2010: 226 days median2011: 95 days median2012: 131 days median2016: 163 days median2017: 209 days median2020: 131 days median2021: 83 days median2022: 150 days median2024: 91 days median2025: 87 days median
2007high 226 (2010) · low 65 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MEH

1in 2025

2007: 32008: 802009: 512010: 162011: 42012: 32014: 12015: 12016: 42017: 12018: 32020: 12025: 12026 (partial year): 1
2007high 80 (2008) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MEH

470in 2025

2007: 252008: 2612009: 5392010: 4622011: 4192012: 1,6062013: 1,2952014: 1,1962015: 4902016: 3472017: 3832018: 3372019: 3352020: 3382021: 3722022: 3162023: 3342024: 3542025: 470
2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—325
200867980261
200966551539
2010522616462
20115954419
2012613131,606
20131—01,295
20140—11,196
20152—1490
201661634347
201732091383
20182—3337
20191—0335
202031311338
20213830372
202231500316
20232—0334
20246910354
20255871470
20261—1—

What is it indicated for?

1. Non-inflammatory degenerative joint disease Including osteoarthritis and avascular necrosis.

2. 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 of previously failed total hip arthroplasty.

This device is a single use implant and intended for cementless use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K090757

6 other devices cite the same predicate.

  • K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
  • K152621OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015
  • K151603Arcos One-piece Femoral Revision SystemBiomet, Inc. · 2015
  • K130063Arcos Trochanter ButtonBiomet, Inc. · 2013
  • K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp · 2010
  • K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 20101 recall

More from United Orthopedic Corporation

41 FDA decisions under this applicant name. See the company

  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation · 2025
  • K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
  • K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025
  • K243466Conformity Stem Extension Line, #0United Orthopedic Corporation · 2025

Recent decisions in MEH

The MEH category page

  • K261576Icona Hip StemCorin, Ltd. · 2026
  • K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
  • K251166Mfinity Femoral SystemMedacta International S.A. · 2025
  • K251052Trivicta® Hip StemOrtho Development Corp. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

https://510kreport.com/device/K242315 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242315: Resolve Modular Revision Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242315

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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