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Data / Medical devices / United States / Fusion Orthopedics Usa, LLC

Fusion Orthopedics Usa, LLC: FDA-registered device maker in Mesa, AZ, United States, 19 510(k) clearances

Fusion Orthopedics Usa, LLC is registered with the FDA (registration 3013365802) in Mesa, AZ, United States. It lists 14 device types. The FDA files 19 510(k) clearances under its listings, the newest dated March 18, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Fusion Orthopedics Usa, LLC
FDA registration number
3013365802
Address
6859 E Rembrandt Ave Ste 122, Mesa, AZ, United States, 85212
Owner or operator
Fusion Orthopedics, LLC. (10053147)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
November 3, 2016
Registered through
2026
Brand names listed
Bolo Button, Bone Harvester, Bone Tamp, DynaBridge, FibFix Nail, FuzeFix Large, FuzeFix Max FT, FuzeFix Mini and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Complaint file establishment, Specification developeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Complaint file establishment, Specification developeraccessdata.fda.gov
Gauge, DepthHTJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Complaint file establishment, Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishment, Specification developeraccessdata.fda.gov
Prosthesis, Subtalar, Plug, PolymerMJW2Complaint file establishment, Specification developeraccessdata.fda.gov
Prosthesis, Toe, Constrained, PolymerKWH2Complaint file establishment, Specification developeraccessdata.fda.gov
ReamerHTO1Complaint file establishment, Specification developeraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Complaint file establishment, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Specification developeraccessdata.fda.gov
Staple, Fixation, BoneJDR2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
TemplateHWT1Complaint file establishment, Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 18, 2026K252961Fusion FibFix NailHSBSubstantially EquivalentFusion Orthopedics USA, LLCaccessdata.fda.gov
December 23, 2024K242091Bolo Button SystemHTNSubstantially EquivalentFusion Orthopedicsaccessdata.fda.gov
May 30, 2024K233025Revolution External Plating SystemKTTSubstantially EquivalentNew Standard Device Dba Metalogixaccessdata.fda.gov
August 2, 2023K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsMBISubstantially EquivalentGm Dos Reis Industria E Comerico Ltda.accessdata.fda.gov
March 4, 2022K211843PolyLock Plating SystemHRSSubstantially EquivalentFusion Orthopedicsaccessdata.fda.gov
November 25, 2020K193377TopLock Anchor SystemMBISubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
November 24, 2020K202959PolyLock Plating SystemHRSSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
November 18, 2019K192323PolyLock Small Bone Plating SystemHRSSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
October 21, 2019K190136Fusion Silastic SystemKWHSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
May 29, 2019K181630Revolution External Plating SystemKTTSubstantially EquivalentNew Standard Device Dba Metalogixaccessdata.fda.gov
May 21, 2019K182342IntraLock Lapidus SystemHWCSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
November 23, 2018K182684HammerTechTM Fixation SystemHWCSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
October 15, 2018K181815DynaBridgeJDRSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
August 11, 2017K170624TalarLift STSHWCSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
August 7, 2017K170038FuzeFix Screw SystemHWCSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
October 11, 2016K161449HammerTech Fixation SystemHWCSubstantially EquivalentFusion Orthopedics, LLCaccessdata.fda.gov
October 23, 1992K922292LUNDEEN SUBTALAR PEG IMPLANTMJWSubstantially EquivalentSgarlato Laboratories, Inc.accessdata.fda.gov
May 29, 1991K905795SGARLATO FLEXIBLE HINGE TOE IMPLANTKWHSubstantially EquivalentSgarlato Laboratories, Inc.accessdata.fda.gov
May 18, 1989K884739SGARLATO LESSER TOE IMPLANTKWHSubstantially EquivalentSgarlato Laboratories, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 28, 202090670Class IIOngoingMetalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-DrComplaints were received for Self-drill Half-Pin tip breakages occurring during surgery.accessdata.fda.gov
June 8, 202090133Class IICompleted1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.accessdata.fda.gov
August 14, 201990159Class IIOngoingMetalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618ADue to manufacturing processing error, wrench causing stripping when torqueing nuts.accessdata.fda.gov
July 23, 201992390Class IIOngoing'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805The threads on posts stripping out when tensioned during application process.accessdata.fda.gov

Compare with other makers

Updated March 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.