510(k) Report

510(k) · Cleared

Cleared

Ceramic Femoral Head

K103497510(k) TraditionalCleared Mar 4, 201195-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 Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on Mar 4, 2011 after a 95-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Mar 4, 2011
Review
95 days
Class
Class II
Product code
MEH
Recalls
None
Predicates
0

9 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared2011: 1 descendant cleared2013: 2 descendants cleared2017: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2010201520202025
  1. This deviceK103497 Ceramic Femoral HeadUnited Orthopedic Corp. · 2011
  2. Descendant · cites it directly · 8 of its ownK112463 United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation · 2011 · Recalled
  3. Descendant · cites it directly · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
  4. Descendant · 2 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
  5. Descendant · 2 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
  6. Descendant · 2 generations on · 2 of its ownK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011: 12013: 22017: 22018: 12022: 12023: 12026: 1
2011high 2 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 9 · See all
  • K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation · 2011 · cites it directly8descendants
  • K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · cites it directly7descendants
  • K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 2 generations on3descendants
  • K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 2 generations on3descendants
  • K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K103497Ceramic Femoral HeadUnited Orthopedic Corp.2011—
+1K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation20111
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.2013—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation2017—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.2013—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201720
201810
202210
202310
202610
FIG. 1 — Lineage of K103497, 2011–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation20118
K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137
K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220

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?

  • Of its descendants, K112463 (United Orthopedic Corporation, 2011) has gone furthest, with 8 descendants of its own.

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. 2011, 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—

More from United Orthopedic Corp.

20 FDA decisions under this applicant name. See the company

  • K140073U2 Femoral Component, CR, CementedUnited Orthopedic Corp. · 2014
  • K140075U2 Femoral Component, CR, Porous CoatedUnited Orthopedic Corp. · 2014
  • K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
  • K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
  • K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013

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The MEH category page

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https://510kreport.com/device/K103497 · printed Nov 4, 2026

Cite this page

510(k) Report. “K103497: Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103497

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026