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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K250450

Coated hip implants · Medacta International S.A. · decided 2025-09-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
AMIStem-P Collared01.18.434Medacta International SAKWY LPH LZO LZY MEH07630040720236
Quadra R femoral stems01.12.068Medacta International SAJDI07630030802461
AMIStem-P Short Neck 01.18.461Medacta International SALZO07630971243651
Quadra P femoral stems01.12.249Medacta International SAJDI KWY LPH LZO LZY MEH07630971243408
Quadra P femoral stems01.12.164Medacta International SAJDI KWY LPH LZO LZY MEH07630040731881
SMS Stem01.36.064Medacta International SALZO07630030888762
Mpact Acetabular System01.32.154DHMedacta International SALPH LZO07630030810824
Mpact Acetabular System01.32.074MHMedacta International SALPH LZO07630030810688
Mpres Neck Preserving Stem01.37.032Medacta International SALZO MEH07630345713582
Quadra P femoral stems01.12.189Medacta International SAJDI KWY LPH LZO LZY MEH07630040732048
Quadra P femoral stems01.12.165Medacta International SAJDI KWY LPH LZO LZY MEH07630040731898
Quadra H femoral stems01.12.20SNMedacta International SAJDI07630030802607
AMIStem-P Short Neck 01.18.474Medacta International SALZO07630971243781
AMIStem-P Short Neck 01.18.464Medacta International SALZO07630971243682
SMS Stem01.36.072Medacta International SALZO07630030888847
Mpact Acetabular System01.32.146DHMedacta International SALPH LZO07630030810701
Quadra H femoral stems01.12.29SNMedacta International SALZO MEH07630030802690
Quadra R femoral stems01.12.069Medacta International SAJDI07630030802478
Quadra P femoral stems01.12.126Medacta International SALZO07630040720472
Mpact Acetabular System01.32.156MHMedacta International SALPH LZO07630030810862
Mpres Neck Preserving Stem01.37.011Medacta International SALZO MEH07630345713438
Quadra P femoral stems01.12.129Medacta International SALZO07630040720502
Mpact Acetabular System01.32.068RHMedacta International SALPH LZO07630030810633
AMIStem H Collared Femoral Stems01.18.245Medacta International SALZO MEH07630030804700
Mpact Acetabular System01.32.142SHTMedacta International SALPH LZO07630542722226