Medical device manufacturer
Synthes USA
Synthes USA holds 418 FDA 510(k) clearances across 56 product codes. Median elapsed review time is 78 days. openFDA lists 4 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
- 418
- Product codes
- 56
- Median review
- 78 days
- Recall records
- 4
How does FDA spell Synthes USA?
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.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Synthes (USA) | device/recall | normalised |
| Synthes (Usa) | device/510k | normalised |
| Synthes (Usa), LLC | device/510k | normalised |
| Synthes USA | device/recall | normalised |
| Synthes USA | device/enforcement | normalised |
| Synthes USA | device/510k | normalised |
| Synthes USA, LLC | device/510k | normalised |
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 Synthes USA file in?
56 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | 95 | 75 days | |
| JEY | Plate, Bone | 38 | 82 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 32 | 64 days | |
| HWC | Screw, Fixation, Bone | 31 | 78 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 23 | 87 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 17 | 69 days | |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 14 | 71 days | |
| DZL | Screw, Fixation, Intraosseous | 13 | 71 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 13 | 164 days | |
| MQN | External Mandibular Fixator And/Or Distractor | 12 | 78 days | |
| JDS | Nail, Fixation, Bone | 11 | 59 days | |
| JDQ | Cerclage, Fixation | 8 | 67 days | |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 8 | 65 days | |
| MQV | Filler, Bone Void, Calcium Compound | 8 | 33 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 6 | 136 days | |
| HTN | Washer, Bolt Nut | 5 | 85 days | |
| HTY | Pin, Fixation, Smooth | 5 | 84 days | |
| JDO | Device, Fixation, Proximal Femoral, Implant | 5 | 84 days | |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 | 90 days | |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 4 | 35 days | |
| GXP | Methyl Methacrylate For Cranioplasty | 4 | 51 days | |
| GXR | Cover, Burr Hole | 4 | 72 days | |
| JDW | Pin, Fixation, Threaded | 4 | 59 days | |
| JEC | Component, Traction, Invasive | 4 | 87 days | |
| MQP | Spinal Vertebral Body Replacement Device | 4 | 89 days |
Showing the 25 they file in most, of 56.
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 Synthes USA had a recall?
openFDA lists 4 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-0617-2018Class IITerminatedOIS
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
Z-0618-2018Class IITerminatedMQV
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
Z-0460-2012TerminatedMQV
A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
Z-0792-06TerminatedJEY
Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.
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 Synthes USA cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K180821 | TruMatch Graft Cage - Long Bone | HRS | 266 | |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | KTT | 171 | |
| K152239 | Zero-P Natural Plate System | KWQ | 114 | |
| K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM | HRS | 294 | |
| K131984 | SYNTHES SYNSONIC ULNA NAIL | HSB | 276 | |
| K130146 | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM | NDN | 118 | |
| K121601 | SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE | HRS | 35 | |
| K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | KWI | 340 | |
| K120854 | SYNTHES VA LCP ANKLE TRAUMA SYSTEM | HRS | 89 | |
| K120275 | SYNTHES ACIS/VERTEBRAL SPACER CR | ODP | 116 |
Source: openFDA device/510k · retrieved
Watch what Synthes USA files next
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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.