Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009540749

FEI Number

3009540749

Entity Name

Medartis Inc.

City/State/Country

Warsaw, IN, US

Establishment Address

1195 Polk Drive, Warsaw, IN 46582, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MEDARTIS AG (Owner Number: 9033581)

Owner / Operator Contact Address

HOCHBERGERSTRASSE 60E, --, BASEL, CH-BS CH-4057, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191636

PMA Number

N/A

All Registered Proprietary Names

CalcShift Displacement Calcaneal Osteotomy System CalcShift Instrument System APTUS Foot 2.8-3.5 System APTUS Elbow Dorsal Olecranon Plates APTUS Hand System PediFrag Response Spine OrthoPediatrics PediNail Intramedullary Platform PediNail Response Spine APTUS Ulna Shortening 2.5 OrthoPediatrics Cannulated Screw System APTUS Wrist Arthrodesis Plates DFOS APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System SCFE PNP DFOS StealthFix PEDINAIL INTRAMEDULLARY NAILING SYSTEM APTUS 2 Radial Head System APTUS Forearm APTUS K-Wire System Case Box Avenger Radial Head System Modul Rack Dispenser DFOS Container PediFlex Tray APTUS Distal Humerus System PNP APTUS and MODUS Instruments PSN Drop Rod Adapter Lapidus Cut Guide Disposable Set Lapidus Cut Guide Patella Clamp Head PediLoc PediNail Lapiprep Lapidus Preparation System Cannulated Screws LCB StealthFix Intraosseous Fixation System Avenger Radial Head System BandLoc PediFrag PediFlex KeriFlex Instrumentation DFOS CalcShift Instrument System Response Spine PediFoot PNP APTUS Ulna Plates APTUS Elbow Dorsal Olecranon Plates APTUS Wrist 2.5 System APTUS Foot 3.5 System Micro Screw Non-Sterile DFOS APTUS 2/2.3 Four Corner Fusion Plate Cannulated Screws Gen II PNP SCFE PediPlates DFOS LCB MPFL PediLoc Cannulated Screws PediFoot KeriFlex Instrumentation LCB APTUS CMC-I Fusion Plate System Response Spine PediFlex DFOS Cannulated Screws Response Spine APTUS Titanium Fixation System StealthFix Intraosseous Fixation System Touch CMC 1 Prosthesis Instruments Cannulated Screws Gen II TTS-Titanium Trauma Splint Titanium Arch Bar TTS Tooth Splint APTUS Proximal Humerus System APTUS Clavicle APTUS Coronoid 2 APTUS 1.5 TriLock PediFlex Flexible Nail System APTUS Proximal Humerus System APTUS and MODUS Drill Bits LCB PNP PNP PediFlex Response Spine System SCFE APTUS Foot System Staple All-in-One

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-11-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-04-16
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2020-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-05-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-08
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2024-11-05
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-11-05
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2024-11-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-11-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-11-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-07-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-05
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-08-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-10
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2024-11-05
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-11-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-11-11
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-11-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-11
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2024-11-05
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-11-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-10
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-10
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-11-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-12-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-20
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-02-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-02-20
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2010-12-10
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-12-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-02
HWA	Impactor	Orthopedic	Class 1	888.4540	2024-11-05
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1998-04-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-02-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-02-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-07-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-07-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-06-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-06-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-07-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-07-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-18
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-04-18
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2024-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-10
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-11-05
HWQ	Passer	Orthopedic	Class 1	888.4540	2024-11-05
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2025-08-20
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2024-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-08-27
HXB	Probe	Orthopedic	Class 1	888.4540	2024-11-05
HWJ	Awl	Orthopedic	Class 1	888.4540	2024-11-05
HXW	Bender	Orthopedic	Class 1	888.4540	2024-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-10
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-10
SFA	Prosthesis, Finger, Semi-Constrained, Metal/Polymer	Unknown	Class 3	N/A	2025-07-28
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-11-05
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2012-12-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-02-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-02-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-20
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-02-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-02-20
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-08-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-02-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-09-18
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2018-09-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-09-18
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2008-03-14
HTH	Protractor	Orthopedic	Class 1	888.4600	2024-11-05
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2024-11-05
HWB	Extractor	Orthopedic	Class 1	888.4540	2024-11-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-11-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-11-05
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-08-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-08-20
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-08-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDARTIS AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003236702	MEDARTIS AG	BASEL Basel-Stadt, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009540749. Last updated year: 2026. Please use registration number 3009540749 when referencing this establishment in official correspondence.