510(k) · Cleared
ClearedOsteo 4.0MM Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · HWC Screw, Fixation, Bone
Cleared on May 11, 1998 after a 35-day review. The FDA summary names its predicate without a number.
- Decided
- May 11, 1998
- Review
- 35 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Synthes 4.0mm Cannulated Screws in the Synthes 4.0mm Screw Set Named without a submission number | |
| * | — | ACE Medical 4.0mm Cannulated Screws in the ACE Titanium 3.5/4.0mm Small Fragment System Named without a submission number | |
| * | — | Richards 4.0mm Cannulated Screw Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 indications for the use of these cannulated screws, in keeping with those of other legally marketed cannulated screws, are as follows. The Osteo 4.0mm Cannulated Screw System is indicated for osteochrondritis dissecans, ligament fixation, and long and small bone fracture fixation, which may include the following: Fractures of the olecranon, distal humerus Fractures of the ulna and radius Patellar fractures Distal tibia and pilon fractures Fractures…
Read the full statement (101 words)
The indications for the use of these cannulated screws, in keeping with those of other legally marketed cannulated screws, are as follows.
The Osteo 4.0mm Cannulated Screw System is indicated for osteochrondritis dissecans, ligament fixation, and long and small bone fracture fixation, which may include the following:
Fractures of the olecranon, distal humerus
Fractures of the ulna and radius
Patellar fractures
Distal tibia and pilon fractures
Fractures of the tarsals and metatarsals
Tarso-metatarsal and metatarso-phalangeal arthrodeses
Metatarsal and phalangeal osteotomies
Fractures of the posterior wall of the acetabulum and other fractures of the pelvic ring
Other small fragment, cancellous bone fractures
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/K981259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981259: Osteo 4.0MM Cannulated 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/K981259
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026