510(k) · Cleared
ClearedHeadless Compression Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, LLC · HWC Screw, Fixation, Bone
Cleared on Dec 13, 2011 as substantially equivalent to K030302 (Schoening & Assoc., Inc., 2003) after a 90-day review. Its family tree reaches back 1 generation to 2003. 10 later devices descend from it.
- Decided
- Dec 13, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030302 (2003). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK030302 HBS Headless Bone ScrewSchoening & Assoc., Inc. · 2003
- This deviceK112672 Headless Compression ScrewSkeletal Dynamics, LLC · 2011
- Descendant · cites it directly · 7 of its ownK143624 Headless Compression Screw SystemSkeletal Dynamics, LLC · 2015
- Descendant · cites it directly · 4 of its ownK132910 Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC · 2013
- Descendant · 2 generations on · 3 of its ownK142707 AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK201662 REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK192744 CORRIDOR Fixation SystemGlobus Medical, Inc. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K143624Headless Compression Screw SystemSkeletal Dynamics, LLC · 2015 · cites it directly7descendants
- K132910Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC · 2013 · cites it directly4descendants
- K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc. · 2014 · 2 generations on3descendants
- K201662REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc. · 2020 · 2 generations on2descendants
- K192744CORRIDOR Fixation SystemGlobus Medical, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030302 | HBS Headless Bone Screw | Schoening & Assoc., Inc. | 2003 | — |
| 0 (this device) | K112672 | Headless Compression Screw | Skeletal Dynamics, LLC | 2011 | — |
| +1 | K143624 | Headless Compression Screw System | Skeletal Dynamics, LLC | 2015 | — |
| +1 | K132910 | Depuy Synthes Spine Dens Access System | Synthes USA Products, LLC | 2013 | — |
| +2 | K142707 | AIS Odontoid Fracture Fixation System | Aesculap Implant System, Inc. | 2014 | — |
| +2 | K201662 | REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc. | 2020 | — |
| +2 | K192744 | CORRIDOR Fixation System | Globus Medical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K030302 | HBS Headless Bone ScrewSummary page 1…ew System Common Name Screw, fixation, bone Classification 21 CFR §888.3040 Product Code HWC Class Class 11 Predicate Devices: HBS Headless Bone Screw (K030302) Description of the Device: The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titan… | 2003 |
What descends from it? (10)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, ostec-chondral fractures, small joint fusions, carpal…
Read the full statement (85 words)
The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include:
Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, ostec-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112672: Headless Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112672
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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