510(k) Report

510(k) · Cleared

Cleared

Fixos Screw System

K133451510(k) TraditionalCleared Feb 28, 2014108-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Trauma AG · HWC Screw, Fixation, Bone

Cleared on Feb 28, 2014 as substantially equivalent to K000080 (Howmedica Osteonics Corp., 2000) and 2 other predicates after a 108-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.

Decided
Feb 28, 2014
Review
108 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K000080 (2000). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2023: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK000080 · Asnis Iii Cannulated Screw System · Howmedica Osteonics Corp. · 2000 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants K000080 · Asnis Iii Cannulated Screw System · Howmedica Osteonics Corp. · 2000 · recalled0
  1. Root · 1 generation backK000080 Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp. · 2000 · Recalled
  2. This deviceK133451 Fixos Screw SystemStryker Trauma AG · 2014
  3. Descendant · cites it directly · 0 of its ownK262075 Lapidus Screw KitRelja Innovations, LLC · 2026
  4. Descendant · cites it directly · 0 of its ownK250935 TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed…TriMed, Inc. · 2025
  5. Descendant · cites it directly · 0 of its ownK223468 Nexis® compressive screwsNovastep · 2023

Most influential descendants

Showing 3 of 3 · See all
  • K262075Lapidus Screw KitRelja Innovations, LLC · 2026 · cites it directly0descendants
  • K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc. · 2025 · cites it directly0descendants
  • K223468Nexis® compressive screwsNovastep · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000080Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp.20001
0 (this device)K133451Fixos Screw SystemStryker Trauma AG2014—
+1K262075Lapidus Screw KitRelja Innovations, LLC2026—
+1K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth…TriMed, Inc.2025—
+1K223468Nexis® compressive screwsNovastep2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202510
202610
FIG. 1 — Lineage of K133451, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K000080Asnis Iii Cannulated Screw System
Our reading of the summary gave K000050, FDA’s number for Top Quality Chlorinated-Powderfree Examination Gloves (Top Quality Mfg., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Asnis III Cannulated Screw System”.
Howmedica Osteonics Corp.20001
*K080850Darco Headless Compression Screw
Our reading of the summary gave K080550, FDA’s number for Megachannel Endoscopic Overtube, Model OT22 (Minos Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Darco Headless Compression Screw”.
Wrightmedicaltechnologyinc2008—
*K080943Synthes 4.5 MM and 6.5 MM Headless Compression Screws
Summary page 2
…* Asnis IIl Cannulated Screw System-KOOOOSO * Darco Headless Compression Screw-KO80S50 * Synthes 4.5mm and 6.5mm Headless Compression Screws-K080943 26…
Synthes (Usa)2008—

Also cleared against K000080: 20 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K262075Lapidus Screw KitRelja Innovations, LLC20260
K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250
K223468Nexis® compressive screwsNovastep20230

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K262075 (Relja Innovations, LLC, 2026) has gone furthest, with 0 descendants of its own.
  • 20 other devices also cite its predicate K000080.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Stryker Fixes Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include: 04.0mm Headless Screw: * Fractures of the tarsals and metatarsals * Fractures of the olecranon, distal humerus * Fractures of the radius and ulna * Patella fractures * Distal tibia and pilon fractures * Fractures of the fibula, medial malleolus, os calcis *…

Read the full statement (159 words)

The Stryker Fixes Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include:

04.0mm Headless Screw:

* Fractures of the tarsals and metatarsals

* Fractures of the olecranon, distal humerus

* Fractures of the radius and ulna

* Patella fractures

* Distal tibia and pilon fractures

* Fractures of the fibula, medial malleolus, os calcis

* Tarso-metatarsal and metatarsophalangeal arthrodesis

* Metatarsal and phalangeal osteotomies

* Osteochondritis dissecans

* Fractures of the pelvic ring

* Small cancellous fragments of the small and long bones

05.0mm Headless Screw:

* Medial and lateral malleolar and pilon fractures

* Proximal and distal humerus fractures

* Fractures of the olecranon process

* Tibial plateau fractures

* Os calcis, talar and patellar fractures

* Fractures of the pelvis and acetabulum

* Arthrodesis of the tarsals

07.0mm Headless Screw:

* Tibia] plateau fractures

* Ankle artbrodesis

* Calcaneus osteotomies

Indications for use as stated in the FDA summary.

Also cleared against K000080

20 other devices cite the same predicate.

  • K210146Cannulated Compression Device SystemOrthopedic Designs North America, Inc. · 2022
  • K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH · 2022
  • K210754Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
  • K172596Large Screws RangeNewclip Technics · 2017
  • K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc. · 2017
  • K171558ExsoMed ITN Cannulated Screw SystemExsomed Holdings Company, LLC · 2017

More from Stryker Trauma AG

25 FDA decisions under this applicant name. See the company

  • K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total…Stryker Trauma AG · 2017
  • K153154Asnis JFX SystemStryker Trauma AG · 2015
  • K151178VariAx 2 Wrist Fusion SystemStryker Trauma AG · 2015
  • K143138AxSOS 3 Ti Locking Plate SystemStryker Trauma AG · 2014
  • K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K133451 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133451: Fixos 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/K133451

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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