510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Fusion Orthopedics USA, LLC

Mesa, AZ, US

FUSION ORTHOPEDICS USA, LLC appears in FDA device records in Mesa, AZ. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Fusion Orthopedics USA, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • New Standard Device Incenforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Fusion Orthopedics USA, LLC in 2026.

Clearances by year, as a table
510(k) clearance decisions for Fusion Orthopedics USA, LLC, by decision year
YearClearances
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252961Fusion FibFix NailHSBSubstantially Equivalent

Registered establishments

FDA registered establishments for Fusion Orthopedics USA, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30133658023013365802FUSION ORTHOPEDICS USA, LLC6859 E Rembrandt Ave, Mesa, AZ 85212 US2026and 4 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1649-2022Metalogix 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-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.Class IIOpen, Classified
Z-1236-20221.8mm 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.Class IICompleted
Z-1280-2022Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618ADue to manufacturing processing error, wrench causing stripping when torqueing nuts.Class IIOpen, Classified
Z-1824-2023'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.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Fusion Orthopedics USA, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain