Atlas FDA

OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM

FDA 510(k) clearance K962152 · decided 1996-08-14

Clearance details

K-number
K962152
Device name
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
Applicant
Osteonics Corp.
Decision
Substantially Equivalent for Some Indications
Date received
1996-06-04
Decision date
1996-08-14
Days to decision
71 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Numb recall (Z-0886-2024)Howmedica Osteonics Corp.2024-01-31
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Numbe recall (Z-0887-2024)Howmedica Osteonics Corp.2024-01-31
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Numbe recall (Z-0888-2024)Howmedica Osteonics Corp.2024-01-31
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Numbe recall (Z-0889-2024)Howmedica Osteonics Corp.2024-01-31
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Numb recall (Z-0890-2024)Howmedica Osteonics Corp.2024-01-31
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Numbe recall (Z-0891-2024)Howmedica Osteonics Corp.2024-01-31
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Numbe recall (Z-0892-2024)Howmedica Osteonics Corp.2024-01-31
Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of recall (Z-1634-2015)Stryker Howmedica Osteonics Corp.2015-05-19
Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inse recall (Z-0795-2010)Stryker Howmedica Osteonics Corp.2010-02-19
Scorpio PS Femur Waffle Posts with LfIt; Stryker Orthopaedics, 325 Corporate Drive, Mahwah recall (Z-0469-2010)Stryker Howmedica Osteonics Corp.2009-12-01
Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, lo recall (Z-2079-2008)Stryker Howmedica Osteonics Corp.2008-09-16
Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, L recall (Z-1814-2008)Stryker Howmedica Osteonics Corp.2008-09-11
Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibia recall (Z-1382-2008)Stryker Howmedica Osteonics Corp.2008-07-16