Medical device manufacturer
Smith & Nephew, Inc.
Smith & Nephew, Inc. holds 555 FDA 510(k) clearances across 102 product codes. Median elapsed review time is 82 days. openFDA lists 448 recall records naming the company. FDA publishes it under 14 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 555
- Product codes
- 102
- Median review
- 82 days
- Recall records
- 448
How does FDA spell Smith & Nephew, Inc.?
FDA publishes this company under 14 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 |
|---|---|---|
| SMITH & NEPHEW INC. | device/registrationlisting | normalised |
| SMITH & NEPHEW, INC. | device/registrationlisting | normalised |
| Smith & Nephew | device/510k | normalised |
| Smith & Nephew Inc | device/enforcement | normalised |
| Smith & Nephew Inc | device/recall | normalised |
| Smith & Nephew Inc. | device/enforcement | normalised |
| Smith & Nephew Inc. | device/recall | normalised |
| Smith & Nephew, Inc. | device/recall | normalised |
Showing 8 of 14.
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 Smith & Nephew, Inc. file in?
102 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 49 | 77 days | |
| HRS | Plate, Fixation, Bone | 37 | 69 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 32 | 117 days | |
| HWC | Screw, Fixation, Bone | 27 | 77 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 24 | 88 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 23 | 79 days | |
| HRX | Arthroscope | 19 | 53 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 17 | 74 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 16 | 78 days | |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 14 | 100 days | |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 13 | 72 days | |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 13 | 119 days | |
| JDS | Nail, Fixation, Bone | 12 | 54 days | |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 12 | 95 days | |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 11 | 75 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 11 | 79 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 11 | 98 days | |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 11 | 47 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 10 | 64 days | |
| HIH | Hysteroscope (And Accessories) | 10 | 98 days | |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | 9 | 90 days | |
| OLO | Orthopedic Stereotaxic Instrument | 9 | 77 days | |
| HAW | Neurological Stereotaxic Instrument | 8 | 109 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 8 | 61 days | |
| JDW | Pin, Fixation, Threaded | 8 | 66 days |
Showing the 25 they file in most, of 102.
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 Smith & Nephew, Inc. had a recall?
openFDA lists 448 recall records naming this company across its whole history, of which 2 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2456-2026Class IIOpen, ClassifiedHSB
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
Z-0957-2026Class IIOpen, ClassifiedHWC
Removal of affected lot of screws due to labeling error.
Z-1806-2025Class IIOpen, ClassifiedHSB
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Z-0581-2025Class IIOpen, ClassifiedMBI
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Z-0326-2025Class IIOpen, ClassifiedKWY
The Bipolar assembly contains an oversized Retainer Ring.
Showing the 5 most recently initiated of 448.
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 Smith & Nephew, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | MBI | 28 | |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | KWS | 109 | |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | KWS | 89 | |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | PKC | 88 | |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | MBI | 28 | |
| K243608 | TRIGEN Stable Lock Nut & Washer | JDS | 202 | |
| K250677 | LEGION Total Knee System | JWH | 27 | |
| K250571 | CATALYSTEM Femoral Stems | LZO | 30 | |
| K241666 | EVOS Pelvic and Acetabular System | HRS | 254 | |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | HSB | 41 |
Source: openFDA device/510k · retrieved
Where is Smith & Nephew, Inc. registered?
FDA lists 8 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 Smith & Nephew, Inc. 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.