# K170038: FuzeFix Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics, LLC
- Decided: Aug 7, 2017 after 214 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K000684 (2000). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 5.
- K151021: OsteoMed Cannulated Screw System, Osteomed Corp. (2015) Summary page 5.
- K043583: Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003, Wrightmedicaltechnologyinc (2005) Summary page 5.
- K042310: Ortho-Pro Cannulated Bone Screws, Ortho-Pro, LLC (2004) Summary page 5.
- K081510: Tiger Cannulated Screw System, Trilliant Surgical, Ltd. (2008) Summary page 5.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 5.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.
- K944330: Acutrak Plus Fixation System, Acu Med, Inc. (1995) Summary page 5.
- K132217: Arthrex Compression FT Screws, Arthrex, Inc. (2013) Summary page 5.

## Most influential descendants
- K210159: IntraLock System (2021), 0 descendants of its own

## Indications for use
The FuzeFix Mini System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for: scaphoid fractures, capitate fractures, metacarpal fractures, phalangeal fractures, ulnar styloid fractures, small joint fusions, humeral head fractures, intercarpal fractures, tarsal fusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bone fractures, forefoot interfragmentary fractures, lunate fractures, trapezial fractures, metatarsal fractures, radial head fractures, osteo-chondral fractures, glenoid fractures, interphalangeal fractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distal metatarsal osteotomies, midfoot interfragmentary fractures. Not intended for use in the spine. The FuzeFix Large System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Large System is indicated for: joint reconstructions, joint fusions, multiple fragment joint fractures, simple metaphyseal fractures, fractures of the wrist, ankle, elbow, and shoulder, metatarsal fractures and other fractures of the foot, ligament fixation of the proximal humerus, malleolar fractures, navicular fractures, fractures of the calcaneus, fractures of the talus, arthrodesis of the ankle joint, and fractures of the tarsal region. The devices and implants are not intended for use in the spine. The FuzeFix Headless FT System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Headless FT System is indicated for: Osteochondral fragments (talar vault, femoral condyle), apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), cancellous fragments (talus), Carpal, metacarpal, and small hand bone, tarsal and metatarsals, phalanges, Intra-articular fractures, ankle, proximal and distal humerus, proximal and distal radius, proximal and distal ulna, osteochondral fixation and fractures, Osteochondritis Dissecans, Fixation of fractures and osteotomies about the knee, Oblique fractures of the fibula, Reconstructive surgeries of the foot, and malleolar fixation. Not intended for use in the spine. The FuzeFix Twist Off System is intended for use in the stabilization and fixation of bone fractures, osteotomies, and for bone reconstruction of the hand and foot. The FuzeFix Twist Off System is indicated for: fixation of small bone fragments, Weil osteotomy, mono-cortical fixation, osteotomies and fractures fixation in the foot and hand.

Source page: https://510kreport.com/device/K170038
Methodology: https://510kreport.com/methodology