# K210016: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System - Pathway: 510(k) (Traditional) - Applicant: Integra LifeSciences Corporation - Decided: Jul 27, 2021 after 204 days - Product code: HRS (Plate, Fixation, Bone) - Device class: 2 - Regulation: 21 CFR 888.3030 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 10 generations back to K962616 (1996). 103 ancestors in all. No later device cites it as a predicate yet. 0 of 104 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K152527: Integra DigiFuse Cannulated Intramedullary Fusion System, Ascension Orthopedics (2015) Summary page 7. - K123000: Integra Total Foot Systems, Integra LifeSciences Corporation (2012) Summary page 7. - K162153: Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System, Ascension Orthopedics (2017) Summary page 7. - K960692: Subtalar Mba System, Kinetikos Medical, Inc. (1996) Summary page 7. - K111265: Metasurg Subtalar Implant, Metasurg (2011) Summary page 7. - K011262: Modification to the Bold Screw, New Deal, S.A. (2001) Summary page 7. - K083154: Newdeal Hallu Lock Plate System, Newdeal Sas (2009) Summary page 7. - K093781: Modified: Newdeal Hallu Plates, Newdeal Sas (2010) Summary page 7. - K071639: Qwix Positioning Screw, Newdeal Sas (2007) Summary page 7. - K011946: The Spin Snap-Off Screw, New Deal, S.A. (2001) - K073375: Newdeal Tibiaxys System, Newdeal Sas (2008) Summary page 7. ## Indications for use The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include: • Hammer toe deformity • Claw toe deformity • Mallet toe deformity • Other deformities of the feet and hands The DigiFuse® implants are intended for single use only. Integra(r) total foot system is indicated for skeletally mature patients for the following: -stabilization and fixation of fresh fractures -intra and extra articular fractures, joint depression, and multi-fragmentary fractures -revision procedures, joint fusion, and reconstruction of small bones of the feet. The indications for use for the Integra® CAPTURE™ Screw System are as follows: “The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only. The indications for use for the Integra® Ti6® Internal Fixation System are as follows: “The Ti6® Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only. The Subtalar MBA System is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. *Severely pronated foot *Walking intemperence *Calcaneal stance position great than 5 degrees *Manually correctable deformities *Mid-tarsal breech (arch pain) *Forefoot varus greater than 10 degrees The metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and meical displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Indications include: severe pronation Calcaneal valgus deformity plantarflexed talus failed correction with long term orthotic treatment congenital and painful flatfoot deformity repair of tarsal coalitions subtalar instability posterior tibial tendon dysfunction paralytic flat foot deformity The metasurg subtalar implants are intended for single use only. The "new" bold screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - fixation of small bone fragments, in long bones or small bones fractures. - arthrodesis in hand or foot surgery - mono or bi-cortical osteotomies in the foot or hand - distal or proximal metatarsal or metacarpal osteotomies - fixation of osteotomies for hallux valgus treatment (such as scarf, chevron, etc.) The hallu lock plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of: hallux rigidus severe hallux valgus (im angle>20 degrees and hv angle >40 degrees) deformity from rheumatoid arthritis failed previous surgical procedures traumatic arthritis neuromuscular instability the hallu lock plates must be fixed with the surfix fixed angle locking system and with the surfix-alpha variable angle locking system of 2.7mm or 3.0mm diameter (scews and lock-screws). Addition of a newdeal qwix screw crossing the joint is strongly recommended for optimal arthrodesis consolidation. the hallu plates are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarso-phalangeal joint, including cases of: hallux rigidus severe hallux valgus (im angle > 20 degree and hv angle >40 degree) deformity from rheumatoid arthritis failed previous surgical procedure traumatic arthritis neuromuscluar instability The plates have to be fixed with the snap-off screws. Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation. The qwix positioning screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: * mono or bi-cortical osteotomies in the foot or hand (including hallux valgus treatment) * fractures management in the foot or hand * fixation of bone fragments in long bones or small bones fractures *arthrodesis in hand, foot and ankle surgery The size of the chosen screw should be adapted to the specific indication. The "new" spin" snap-off screw is indicated for fixation of bone fractures of for bone reconstruction. Examples include: - fixation of small bone fragments - weil osteomy - mono-cortical fixation - osteotomies and fractures fixation in the foot and hand. The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal TIBIAXYS Plates have to be fixed with the SURFIX and SURFIX ALPHA 3.5mm diameter Locking System (screws and Lock screws). Anterior plates for ankle Arthrodesis have to be fixed with the TIBIAXYS 4.0mm diameter cortical screws. Source page: https://510kreport.com/device/K210016 Methodology: https://510kreport.com/methodology