Skip to content

Medical device manufacturer

Arthrex, Inc.

Arthrex, Inc. holds 350 FDA 510(k) clearances across 40 product codes. Median elapsed review time is 90 days. openFDA lists 28 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
350
Product codes
40
Median review
90 days
Recall records
28

How does FDA spell Arthrex, Inc.?

FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
ARTHREX GMBHdevice/registrationlistingnormalised
ARTHREX, INC.device/registrationlistingnormalised
Arthrex GmbHdevice/registrationlistingnormalised
Arthrex, Inc.device/enforcementnormalised
Arthrex, Inc.device/510knormalised
Arthrex, Inc.device/recallnormalised
Arthrex, Inc.device/registrationlistingnormalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Arthrex, Inc. file in?

40 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
MBIFastener, Fixation, Nondegradable, Soft Tissue5263 days
HWCScrew, Fixation, Bone4689 days
MAIFastener, Fixation, Biodegradable, Soft Tissue4583 days
HRSPlate, Fixation, Bone3985 days
HRXArthroscope27115 days
GATSuture, Nonabsorbable, Synthetic, Polyethylene1995 days
HTNWasher, Bolt Nut1685 days
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented15134 days
HTYPin, Fixation, Smooth13106 days
PHXShoulder Prosthesis, Reverse Configuration11119 days
GCJLaparoscope, General & Plastic Surgery9111 days
HSBRod, Fixation, Intramedullary And Accessories6234 days
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented5145 days
JDRStaple, Fixation, Bone558 days
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer448 days
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer476 days
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer350 days
JDQCerclage, Fixation3141 days
QHEShoulder Arthroplasty Implantation System3163 days
FMFSyringe, Piston233 days
FRODressing, Wound, Drug277 days
GEIElectrosurgical, Cutting & Coagulation & Accessories215 days
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained229 days
GASSuture, Nonabsorbable, Synthetic, Polyester1477 days
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment1142 days

Showing the 25 they file in most, of 40.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Arthrex, Inc. had a recall?

openFDA lists 28 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

  • Z-0465-2023Class IIOpen, ClassifiedMDM

    The devices may be packaged with the wrong reamer size.

  • Z-1035-2022Class IITerminatedLXH

    Products do not meet length and diameter specifications.

  • Z-2107-2021Class IIOpen, ClassifiedMAI

    Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

  • Z-1380-2021Class IITerminatedHRS

    It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

  • Z-1310-2021Class IITerminatedHTW

    The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

Showing the 5 most recently initiated of 28.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Arthrex, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K260018Arthrex FiberButtonMBI172
K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemHWC105
K253931Arthrex Bioabsorbable PushLock Suture AnchorsMAI170
K254215Arthrex Beaming SystemHWC130
K260561Arthrex FiberTak Suture AnchorMBI29
K252016Arthrex Humeral NailsHSB266
K260405FiberTape ButtonMBI28
K252196Arthrex FibuLock Nail SystemHSB234
K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonHRS28
K254229Arthrex Nano FiberTak Suture AnchorMBI63

Source: openFDA device/510k · retrieved

Where is Arthrex, Inc. registered?

FDA lists 4 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what Arthrex, Inc. files next

Get an email when this company clears a new device, or when anything is recalled in a product code you follow.

Start watching with DeviceSignal

Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.