510(k) · Cleared
Recalled · Class II · 2013Mini Cannulated Headed and Headless Screw Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instratek, Inc. · HWC Screw, Fixation, Bone
Cleared on May 17, 2012 as substantially equivalent to K063298 (Osteomed LP, 2007) and 11 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1996. 39 later devices descend from it. It has been recalled once.
- Decided
- May 17, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 12
Its longest line of descent runs back 6 generations to K962823 (1996). 37 ancestors in all, the oldest K792022 (1979). 39 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 3 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 2 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 1 generation backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- This deviceK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012
- Descendant · cites it directly · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- Descendant · 2 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · cites it directly · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- Descendant · 4 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · cites it directly36descendants
- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 2 generations on21descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
- K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · cites it directly9descendants
- K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −2 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −1 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| 0 (this device) | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | — |
| +1 | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | 2 |
| +2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| +3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +1 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
| +4 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (12)
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 1…ice classification name: Screw, Fixation, Bone. HWC at 21 CIFR Part 886.3040 Legally marketed device to Osteomed K(063298 which the device is Osteomed K(010783 substantially equivalent: Koby Surgical K060026… | 2007 |
| * | K010783 | 2.0/2.4 Cannulated Screw SystemSummary page 1…HWC at 21 CIFR Part 886.3040 Legally marketed device to Osteomed K(063298 which the device is Osteomed K(010783 substantially equivalent: Koby Surgical K060026 BioPro K(101030… | 2001 |
| * | K060026 | Koby Surgical Internal Fixation SystemSummary page 1…ally marketed device to Osteomed K(063298 which the device is Osteomed K(010783 substantially equivalent: Koby Surgical K060026 BioPro K(101030 Memometal K(070039… | 2006 |
| * | K101030 | Modification to HBS Headless Bone ScrewSummary page 1…h the device is Osteomed K(010783 substantially equivalent: Koby Surgical K060026 BioPro K(101030 Memometal K(070039 Vilex K973309, 1<99111… | 2010 |
| * | K070039 | Memometal Fixos ScrewsSummary page 1…tantially equivalent: Koby Surgical K060026 BioPro K(101030 Memometal K(070039 Vilex K973309, 1<9911197,1K991151 Vilex… | 2007 |
| * | K973309 | Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewSummary page 1…BioPro K(101030 Memometal K(070039 Vilex K973309, 1<9911197,1K991151 Vilex K014154 Instratelk… | 1998 |
| * | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX… | 1999 |
| * | K991151 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone ScrewSummary page 1…BioPro K(101030 Memometal K(070039 Vilex K973309, 1<9911197,1K991151 Vilex K014154 Instratelk 1(960537,K196… | 1999 |
| * | K014154 | Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…Summary page 1…Memometal K(070039 Vilex K973309, 1<9911197,1K991151 Vilex K014154 Instratelk 1(960537,K1960533, K(950704 Description of the device: The Instrate… | 2002 |
| * | K960537 | K2 Bone Screw SystemSummary page 1…Vilex K973309, 1<9911197,1K991151 Vilex K014154 Instratelk 1(960537,K1960533, K(950704 Description of the device: The Instratek Mini Cannulated Titanium Headed and Headless… | 1996 |
| * | K960533 | K3 Bone Screw SystemSummary page 1…ex K973309, 1<9911197,1K991151 Vilex K014154 Instratelk 1(960537,K1960533, K(950704 Description of the device: The Instratek Mini Cannulated Titanium Headed and Headless… | 1996 |
| * | K950704 | K4 Bone Screw SystemSummary page 1…K973309, 1<9911197,1K991151 Vilex K014154 Instratelk 1(960537,K1960533, K(950704 Description of the device: The Instratek Mini Cannulated Titanium Headed and Headless S… | 1995 |
What descends from it? (39)
See all 394 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2013 | Class II | Z-2679-2014 | Nonconforming Material/Component | Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 37 ancestors have a recall of any class.
- Of its descendants, K123890 (Acumed, LLC, 2013) has gone furthest, with 36 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. 2012, 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 Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5mm, 3.0mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, 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 (176 words)
The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5mm, 3.0mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, 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 Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
* Scaphoid Fractures
* Capitate
* Metacarpal Fractures
* Phalangeal Fractures
* Ulnar Styloid Fractures
* Small Joint Fusion
* Humeral head Fractures
* Intercarpal Fractures
* Tarsal Fusions
* Patellar Fractures
* lnterfragmentary Ulnar Fractures
* Small Hand and Wrist Bone Fractures
* Forefoot Interfragmentary Fractures
* Lunate Fractures
* Trapezial Fractures
* Metatarsal Fractures
* Radial Head Fractures
* ste-Chondral
* Ostero-Chondral Fractures
* Glenoid Fractrures;
* Interphalangeal Fractures
* Malleolar Fractures
* Metaphyseal Fratures
* Interfragmentary Radius Fractures
* Distal Metatarsal Osteotomies
* Midfoot lnterfragmentary Fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120493: 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/K120493
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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