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Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. vs G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet: FDAPulse comparison

Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp.'s review days of 154 is 1.1x G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet's 145 (57th percentile). Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. is dated 2026-09-24; G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet 2026-09-23.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. compare to G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet?

FieldPediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp.G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet
Record510(k) clearance510(k) clearance
510(k) numberK261345K261453
DevicePediatric Nailing Platform FemurG7® Acetabular System
ApplicantOrthoPediatrics Corp.Zimmer Biomet
Specialty / panelOrthopedicOrthopedic
Product codeHSBLPH
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-04-232026-05-01
Decision date2026-09-242026-09-23
Review time (days)154145
Third-party reviewNoNo
Applicant locationWarsaw, IN, USWarsaw, IN, US
amount percentile57th54th
Predicate Speed & CAPA Advisory Opportunity Score48/10036/100
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Official records: Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. · G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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