Company · US
Smith & Nephew, Inc., Endoscopy Div.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2024. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NBH | Accessories, Arthroscopic | 5 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 4 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| HWR | Driver, Prosthesis | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 26, 2024 | K242631 | REGENETEN Bioinductive Implant Smith & Nephew Inc., Endoscopy Div. | OWY |
| Nov 14, 2011 | K111843 | ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM Smith & Nephew Inc., Endoscopy Div. | OLO |
| Jan 5, 2011 | K102544 | SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY Smith & Nephew Inc., Endoscopy Div. | KCT |
| Sep 14, 2010 | K092551 | SMITH & NEPHEW INSTRUMENT TRAYS Smith & Nephew Inc., Endoscopy Div. | KCT |
| Apr 19, 2010 | K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div. | MBI |
| Mar 5, 2010 | K093943 | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM Smith & Nephew Inc., Endoscopy Div. | MBI |
| Mar 4, 2010 | K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div. | MBI |
| May 21, 2008 | K073551 | SMITH & NEPHEW INSTRUMENT TRAYS Smith & Nephew Inc., Endoscopy Div. | KCT |
| Apr 23, 2008 | K080358 | PLLA, HA SCREW Smith & Nephew Inc., Endoscopy Div. | HWC |
| Mar 6, 2007 | K063726 | PLC SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div. | HRS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2016 | Smith & Nephew, Inc., Endoscopy Div. Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument Terminated |
NBH | None listed |
| Jan 29, 2016 | Smith & Nephew, Inc., Endoscopy Div. Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument Terminated |
HWR | None listed |
| Oct 22, 2015 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile
Part Number: 7209237
Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated |
HWE | K964215 |
| Oct 22, 2015 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile
Part Number: 7209236
Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated |
HWE | K964215 |
| Oct 22, 2015 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile
Part Number: 7209235
Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated |
HWE | K964215 |
| Oct 22, 2015 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile
Part Number: 7209234
Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated |
HWE | K964215 |
| Jul 30, 2013 | Smith & Nephew, Inc., Endoscopy Div. High Flow Irrigation Extender; Part Number 72201021.
Arthroscopic accessories are indicated for use in access of the joint capsule. Terminated |
NBH | None listed |
| Nov 24, 2009 | Smith & Nephew, Inc., Endoscopy Div. AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device. Terminated |
NBH | None listed |
| Nov 24, 2009 | Smith & Nephew, Inc., Endoscopy Div. AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716.
The product is an orthopedic device. Terminated |
NBH | None listed |
| Nov 24, 2009 | Smith & Nephew, Inc., Endoscopy Div. AlMER ENDOFEMORAL 4MM OFFSET (PURPLE)
Part Number 72201714.
The product is an orthopedic device. Terminated |
NBH | None listed |
| Jan 11, 2006 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile)
Reference Number: 7210430 Terminated |
LXH | None listed |
| Jul 7, 2005 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew Grasper, Cupped 3.4mm
REF: 011014 Terminated |
GDJ | None listed |