510(k) · Cleared
ClearedMini Cannulated Headed and Headless Screw Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HWC Screw, Fixation, Bone
Cleared on Jun 10, 2019 as substantially equivalent to K120493 (Instratek, Inc., 2012) after a 214-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jun 10, 2019
- Review
- 214 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962823 (1996). 38 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 5 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 4 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 3 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 2 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 1 generation backK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- This deviceK183104 Mini Cannulated Headed and Headless Screw SetStryker GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −6 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −5 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −4 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −3 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −2 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −1 | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | 1 |
| 0 (this device) | K183104 | Mini Cannulated Headed and Headless Screw Set | Stryker GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (1)
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 |
|---|---|---|---|
| * | K120493 | Mini Cannulated Headed and Headless Screw SetSummary page 5…November 7, 2018 Primary Predicate: Mini Cannulated Titanium Headed and Headless Screw Set (K120493) Description The Mini Cannulated Titanium Headed and Headless Screw Set consists of cannulated screws with diameters ranging fr… | 2012 |
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.
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 38 ancestors have a recall of any class.
- 3 other devices also cite its predicate K120493.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Stryker Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm, and 4.0 mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, hand surgery, orthopedic surgery, plastic surgery, and podiatric surgery. These devices are…
Read the full statement (180 words)
The Stryker Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm, and 4.0 mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, hand surgery, orthopedic surgery, plastic surgery, and podiatric surgery. These devices are not intended for use in the spine.
The Stryker Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
- Scaphoid fractures
- Lunate fractures
- Capitate fractures
- Trapezial fractures
- Metacarpal fractures
- Metatarsal fractures
- Phalangeal fractures
- Radial head fractures
- Ulnar styloid fractures
- Small joint fusion
- Osteochondral fractures
- Humeral head fractures
- Glenoid fractures
- Carpometacarpal joint fractures
- Interphalangeal joint fractures
- Tarsal fusions
- Malleolar fractures
- Patellar fractures
- Metaphyseal fractures
- Interfragmentary radius fractures
- Interfragmentary ulnar fractures
- Small hand and wrist bone fractures
- Distal metatarsal osteotomies
- Forefoot interfragmentary fractures
- Midfoot interfragmentary 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/K183104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183104: Mini Cannulated Headed and Headless Screw Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183104
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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