Atlas FDA

2 PIECE MODULAR HIP STEM

FDA 510(k) clearance K013106 · decided 2002-04-03

Clearance details

K-number
K013106
Device name
2 PIECE MODULAR HIP STEM
Applicant
Howmedica Osteonics Corp.
Decision
Substantially Equivalent
Date received
2001-09-17
Decision date
2002-04-03
Days to decision
198 days
Clearance type
Traditional
Product code
LZO
Device class
2
Regulation number
888.3353
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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MobileLink Acetabular Cup System – 40mm ID Inserts (various) (K261009)Waldemar Link GmbH & Co. KG2026-07-06
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Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (K253171)Maxx Orthopedics, Inc.2026-01-15
Coated hip implants (K250450)Medacta International S.A.2025-09-19
Longboard Revision Hip Stem (K243021)Signature Orthopaedics Pty, Ltd.2025-08-07
Z1 Hip System (K251906)Zimmer, Inc.2025-07-18
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Recalls involving this device

RecordFirmDate
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill In recall (Z-2487-2012)Stryker Howmedica Osteonics Corp.2012-09-28
Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Tit recall (Z-1102-2010)Stryker Howmedica Osteonics Corp.2010-03-11
Restoration Modular Conical Distal Bowed Stem. 14 mm x 195 mm; Stryker Orthopaedics. Inten recall (Z-2145-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Conical Distal Bowed Stem. 14 mm x 235 mm; Stryker Orthopaedics. Inten recall (Z-2146-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular hip System, Conical Distal Stem, 14 mm x 155 mm; Straight, Cementless recall (Z-2147-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System, Conical Distal Stem, 15 mm x 155 mm; Straight, Cementless recall (Z-2148-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System, Conical Distal Stem, 14 mm x 195 mm; Straight, Cementless recall (Z-2149-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Proximal Broached Body, Size 5; Stryker Orthopaedics. Intended to be u recall (Z-2150-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Proximal Broached Body, Size 6; Stryker Orthopaedics. Intended to be u recall (Z-2151-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Proximal Broached Body, Size 7; Stryker Orthopaedics. Intended to be u recall (Z-2152-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Proximal Broached Body, Size 8; Stryker Orthopaedics. Intended to be u recall (Z-2153-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Calcar Body, 19 mm +10 mm; Stryker Orthopaedics. Intended to be used f recall (Z-2154-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Calcar Body, 23 mm +10 mm; Stryker Orthopaedics. Intended to be used f recall (Z-2155-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Calcar Body, 27 mm +10 mm; Stryker Orthopaedics. Intended to be used f recall (Z-2156-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Calcar Body, 31 mm +10 mm; Stryker Orthopaedics. Intended to be used f recall (Z-2157-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Calcar Body, 25 mm +20 mm; Stryker Orthopaedics. Intended to be used f recall (Z-2158-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 19 mm +0 mm (STD); Not for use with + recall (Z-2159-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 21 mm +0 mm (STD); Not for use with + recall (Z-2160-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 23 mm +0 mm (STD); Not for use with + recall (Z-2161-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 25 mm +0 mm (STD); Not for use with + recall (Z-2162-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 27 mm +0 mm (STD); Not for use with + recall (Z-2163-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 29 mm +0 mm (STD); Not for use with + recall (Z-2164-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 31 mm +0 mm (STD); Not for use with + recall (Z-2165-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 21 mm +10 mm; Not for use with + 16 V4 recall (Z-2166-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 23 mm +10 mm; Not for use with + 16 V4 recall (Z-2167-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 25 mm +10 mm; Not for use with + 16 V4 recall (Z-2168-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 27 mm +10 mm; Not for use with + 16 V4 recall (Z-2169-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 29 mm +10 mm; Not for use with + 16 V4 recall (Z-2170-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 21 mm +20 mm; Not for use with + 16 V4 recall (Z-2171-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 23 mm +20 mm; Not for use with + 16 V4 recall (Z-2172-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 25 mm +20 mm; Not for use with + 16 V4 recall (Z-2173-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 27 mm +20 mm; Not for use with + 16 V4 recall (Z-2174-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Hip System; Proximal Cone Body; 29 mm +20 mm; Not for use with + 16 V4 recall (Z-2175-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 55 mm; Sterile: Made in the recall (Z-2177-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Calcar Body, 21 mm +20 mm; Stryker Orthopaedics. Intended to be used f recall (Z-2178-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog numbe recall (Z-1642-2009)Stryker Howmedica Osteonics Corp.2009-05-21
Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numb recall (Z-0571-04)Stryker Howmedica Osteonics2004-07-20

PMA approvals by this applicant

RecordFirmDate
Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027)Howmedica Osteonics Corp.2025-09-17
Trident Acetabular System: Trident Alumina Inserts (P000013/S026)Howmedica Osteonics Corp.2025-05-23
Trident® Acetabular System (P000013/S025)Howmedica Osteonics Corp.2024-03-08
Trident(R), ABC(R) (P000013/S024)Howmedica Osteonics Corp.2024-01-23
Trident Ceramic System (P000013/S021)Howmedica Osteonics Corp.2023-12-20
Trident(R), ABC(R) (P000013/S023)Howmedica Osteonics Corp.2023-12-19
Trident®, ABC® (P000013/S022)Howmedica Osteonics Corp.2023-09-27
Trident Acetabular System: Trident Alumina Inserts (P000013/S020)Howmedica Osteonics Corp.2022-04-01