ClearanceBrief
Company ยท US

Stryker Howmedica Osteonics Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2006. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
528recalls (0 in 12 months)
360recalls that name a 510(k)

Product codes

CodeDeviceRecords
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate88
LXHOrthopedic Manual Surgical Instrument72
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer64
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented51
KWLProsthesis, Hip, Hemi-, Femoral, Metal43
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented37
HWCScrew, Fixation, Bone30
HSBRod, Fixation, Intramedullary And Accessories21
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish19
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented18
HTWBit, Drill8
HWAImpactor7
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer6
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component5
HRSPlate, Fixation, Bone4
HTOReamer4
HWTTemplate4
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4
JDBProsthesis, Elbow, Semi-Constrained, Cemented3
JDSNail, Fixation, Bone3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 7, 2006K061493APEX PINS
Stryker Howmedica Osteonics
JDW

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 26, 2017Stryker Howmedica Osteonics Corp.
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb
Terminated
KTTK153377
Dec 2, 2016Stryker Howmedica Osteonics Corp.
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg a
Terminated
LXHNone listed
Nov 9, 2016Stryker Howmedica Osteonics Corp.
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporar
Terminated
NDENone listed
Oct 7, 2016Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
Terminated
HWAK153345
Sep 13, 2016Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for th
Terminated
MBHK033972
Sep 13, 2016Stryker Howmedica Osteonics Corp.
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of
Terminated
HSBK010801
Sep 13, 2016Stryker Howmedica Osteonics Corp.
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and close
Terminated
HSBK023267
Aug 29, 2016Stryker Howmedica Osteonics Corp.
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip repla
Terminated
JDIK022077
Aug 11, 2016Stryker Howmedica Osteonics Corp.
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and lo
Terminated
JDIK110290
Jun 23, 2016Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total
Terminated
JWHK143393
Jun 23, 2016Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, t
Terminated
MBHK123486
Jun 3, 2016Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Terminated
LPHK151264
Apr 18, 2016Stryker Howmedica Osteonics Corp.
VariAx Compression Plating System
Terminated
HWCK130009
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
HSBK131365
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYK123604
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
HSBK123401
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
HSBK063225
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
MAYNone listed
Dec 23, 2015Stryker Howmedica Osteonics Corp.
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Terminated
JDRK031127
Dec 2, 2015Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adapto
Terminated
JWHK973164
Nov 17, 2015Stryker Howmedica Osteonics Corp.
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with P
Terminated
JDINone listed
Nov 10, 2015Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Terminated
LPHK121308
Nov 9, 2015Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capt
Terminated
JWHK123486
Sep 23, 2015Stryker Howmedica Osteonics Corp.
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Terminated
LPHK033716
Aug 20, 2015Stryker Howmedica Osteonics Corp.
Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
Terminated
KXEK061146
Aug 20, 2015Stryker Howmedica Osteonics Corp.
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
Terminated
JDBK102180
Aug 20, 2015Stryker Howmedica Osteonics Corp.
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
Terminated
JDBK070236
Aug 20, 2015Stryker Howmedica Osteonics Corp.
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
Terminated
KXEK061146
Aug 20, 2015Stryker Howmedica Osteonics Corp.
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
Terminated
JDBK102180
Aug 14, 2015Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
Terminated
MBHK141056
Aug 10, 2015Stryker Howmedica Osteonics Corp.
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat
Terminated
JWHK141056
Aug 10, 2015Stryker Howmedica Osteonics Corp.
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stry
Terminated
KWSK103835
May 19, 2015Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
Terminated
JWHK042993
K070095
May 19, 2015Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
Terminated
JWHK030978
K042343 +2
May 19, 2015Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acet
Terminated
LPHK102019
May 14, 2015Stryker Howmedica Osteonics Corp.
Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (M
Terminated
JWHK904208
Mar 16, 2015Stryker Howmedica Osteonics Corp.
Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resect
Terminated
MBHK123486

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