510(k) · Cleared
ClearedFuzeFix Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fusion Orthopedics, LLC · HWC Screw, Fixation, Bone
Cleared on Aug 7, 2017 as substantially equivalent to K063298 (Osteomed LP, 2007) and 8 other predicates after a 214-day review. Its family tree reaches back 8 generations to 2000. 1 later device descends from it.
- Decided
- Aug 7, 2017
- Review
- 214 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K000684 (2000). 50 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 6 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 5 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 4 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 3 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 2 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 1 generation backK132217 Arthrex Compression FT ScrewsArthrex, Inc. · 2013
- This deviceK170038 FuzeFix Screw SystemFusion Orthopedics, LLC · 2017
- Descendant · cites it directly · 0 of its ownK210159 IntraLock SystemFusion Orthopedics, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K210159IntraLock SystemFusion Orthopedics, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −7 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −6 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −5 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −4 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −3 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −1 | K132217 | Arthrex Compression FT Screws | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K170038 | FuzeFix Screw System | Fusion Orthopedics, LLC | 2017 | — |
| +1 | K210159 | IntraLock System | Fusion Orthopedics, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 5…on 21 CFR section 888.3040 Device Panel Orthopedic Primary Predicate Device Osteomed ExtremiFix Cannulated Screw System, Wright Medical (K063298 / K151021) CHARLOTTE™ Snap-Off Screw, Wright Medical (K043583) Cannulated… | 2007 |
| * | K151021 | OsteoMed Cannulated Screw SystemSummary page 5…21 CFR section 888.3040 Device Panel Orthopedic Primary Predicate Device Osteomed ExtremiFix Cannulated Screw System, Wright Medical (K063298 / K151021) CHARLOTTE™ Snap-Off Screw, Wright Medical (K043583) Cannulated Bone Screw… | 2015 |
| * | K043583 | Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003Summary page 5…Predicate Device Osteomed ExtremiFix Cannulated Screw System, Wright Medical (K063298 / K151021) CHARLOTTE™ Snap-Off Screw, Wright Medical (K043583) Cannulated Bone Screws, OrthoPro, LLC (K042310) Secondary Predicate Tiger Cannulated Screw Sys… | 2005 |
| * | K042310 | Ortho-Pro Cannulated Bone ScrewsSummary page 5…cal (K063298 / K151021) CHARLOTTE™ Snap-Off Screw, Wright Medical (K043583) Cannulated Bone Screws, OrthoPro, LLC (K042310) Secondary Predicate Tiger Cannulated Screw System, Trilliant Surgical (K081510) Devices Synthes Cannul… | 2004 |
| * | K081510 | Tiger Cannulated Screw SystemSummary page 5…edical (K043583) Cannulated Bone Screws, OrthoPro, LLC (K042310) Secondary Predicate Tiger Cannulated Screw System, Trilliant Surgical (K081510) Devices Synthes Cannulated Screws, Synthes (K963172 / K021932) Acutrak® 2 Screw Sy… | 2008 |
| * | K963172 | Synthes Sterile 4.5 MM Cannulated ScrewsSummary page 5…oPro, LLC (K042310) Secondary Predicate Tiger Cannulated Screw System, Trilliant Surgical (K081510) Devices Synthes Cannulated Screws, Synthes (K963172 / K021932) Acutrak® 2 Screw System, Acumed (K944330) Arthrex Compression FT… | 1996 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 5…(K042310) Secondary Predicate Tiger Cannulated Screw System, Trilliant Surgical (K081510) Devices Synthes Cannulated Screws, Synthes (K963172 / K021932) Acutrak® 2 Screw System, Acumed (K944330) Arthrex Compression FT Screws, A… | 2002 |
| * | K944330 | Acutrak Plus Fixation SystemSummary page 5…rilliant Surgical (K081510) Devices Synthes Cannulated Screws, Synthes (K963172 / K021932) Acutrak® 2 Screw System, Acumed (K944330) Arthrex Compression FT Screws, Arthrex (K132217) Reference Predicate Kangli Pedicle Screw Sys… | 1995 |
| * | K132217 | Arthrex Compression FT ScrewsSummary page 5…rews, Synthes (K963172 / K021932) Acutrak® 2 Screw System, Acumed (K944330) Arthrex Compression FT Screws, Arthrex (K132217) Reference Predicate Kangli Pedicle Screw System, Suzhou Kangli Orthopaedics Instrument Co., Ltd (K140053 / Devices… | 2013 |
| † | K140053 | Kangli Pedicle Screw Spinal System | 2014 |
| † | K142290 | KangLi pedical screw spinal system | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210159 | IntraLock System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 50 ancestors have a recall of any class.
- Of its descendants, K210159 (Fusion Orthopedics, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K063298.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
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…
Read the full statement (383 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170038: FuzeFix Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170038
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026