Prosthesis, Toe, Constrained, Polymer
Orthopedic · 21 CFR 888.3720
Recent MDR events
149 adverse event reports on file
- IMPLANT, 10MM CLEAR STERILE INTERPHLEXApr 27, 2026InjuryOsteomed Llc2027754-2026-00014
- SILKTOE SPACERFeb 25, 2026InjuryBrm Extremities S.r.l.3016669046-2026-00001
- FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS 1Feb 13, 2026InjuryWright Medical Technology Inc3010667733-2026-00119
- RTSJan 22, 2026InjuryConmed3011580264-2026-00002
- RTS LESSEROct 16, 2025InjuryIn2bones Usa3011580264-2025-00012
- RTS LESSEROct 16, 2025InjuryIn2bones Usa3011580264-2025-00013
- RTSAug 27, 2025InjuryIn2bones Usa3011580264-2025-00010
- RTSJun 10, 2025InjuryIn2bones Usa3011580264-2025-00007
- RTSJun 10, 2025InjuryIn2bones Usa3011580264-2025-00008
- PROSTHESIS, TOE, CONSTRAINED, POLYMERMay 19, 2025MalfunctionOsteomed, Llc2027754-2025-00008
Event type breakdown
Recalls
2 recall events for this product code
- Sgarlato Med, LLCTerminatedAug 4, 2010
Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA
Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The outer and inner packages did not match.
Z-2173-2010 · View FDA record ↗ - Tornier, Inc.TerminatedNov 24, 2009
Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435.
Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great Toe Implant With Grommetts).
Z-0455-2010 · View FDA record ↗
Registered firms
69 firms currently registered for this product code
R.k. Manufacturing
Danbury, CT, US
Sterigenics Us Llc
Gurnee, IL, US
Smith & Nephew Orthopaedics Ag
AARAU Aargau, CH
Kingj Medical Co., Ltd
Zhangjiagang Jiangsu, CN
Sterigenics U.s., Llc
Atlanta, GA, US
Stryker Sustainability Solutions Phoenix
Phoenix, AZ, US
Quality Tech Services, Llc
Bloomington, MN, US
Orchid Unique
Bridgeport, MI, US
Isomedix Operations, Inc.
Minneapolis, MN, US
In2bones Usa, Llc
Cordova, TN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Wright Medical Technology, Inc.
Arlington, TN, US
Sterigenics Us Llc
Fort Worth, TX, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Smith And Nephew Operations Sdn. Bhd
Penang Pulau Pinang, MY
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Osteomed
ADDISON, TX, US
Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Zhangjiagang City Jiangsu, CN
Biomet, Inc.
WARSAW, IN, US
Zimmer Biomet Korea Ltd.
Seoul, KR
Sterigenics Us, Llc
Lewis Center, OH, US
Fusion Orthopedics Usa, Llc
Mesa, AZ, US
510(k) clearances
21 clearances for this product code
- Brm ExtremitiesFeb 13, 2020
K191966 · NewPrim System
- Fusion Orthopedics, LLCOct 21, 2019
K190136 · Fusion Silastic System
- In2bones USA, LLCFeb 23, 2018
K173491 · RTS Lesser MTP Implant System
- In2bones USA, LLCSep 8, 2016
K153609 · RTS Flexible 1 MPJ Implant w/Grommets
- Ortho-Pro, LLCJan 14, 2011
K102601 · ORTHOFLEX ROD
- Nexa Orthopedics, Inc.Jan 17, 2003
K023531 · LESSER METATARSAL PHALANGEAL JOINT IMPLANT
- Osteomed Corp.Nov 26, 2002
K022887 · INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
- Osteomed Corp.Nov 25, 2002
K022886 · METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM