510(k) Report

510(k) · Cleared

Cleared

HBS Headless Bone Screw

K030302510(k) TraditionalCleared Aug 8, 2003191-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

Schoening & Assoc., Inc. · HWC Screw, Fixation, Bone

Cleared on Aug 8, 2003 after a 191-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Aug 8, 2003
Review
191 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2018: 1 descendant cleared2015: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2026: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK030302 HBS Headless Bone ScrewSchoening & Assoc., Inc. · 2003
  2. Descendant · cites it directly · 10 of its ownK112672 Headless Compression ScrewSkeletal Dynamics, LLC · 2011
  3. Descendant · 2 generations on · 7 of its ownK143624 Headless Compression Screw SystemSkeletal Dynamics, LLC · 2015
  4. Descendant · 2 generations on · 4 of its ownK132910 Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC · 2013
  5. Descendant · 3 generations on · 3 of its ownK142707 AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc. · 2014
  6. Descendant · 3 generations on · 2 of its ownK201662 REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc. · 2020

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2011: 12013: 12014: 12015: 12018: 12019: 12020: 12022: 12023: 12025: 12026: 2
2011high 2 (2026) · low 0 (2012)2026

Most influential descendants

Showing 5 of 12 · See all
  • K112672Headless Compression ScrewSkeletal Dynamics, LLC · 2011 · cites it directly10descendants
  • K143624Headless Compression Screw SystemSkeletal Dynamics, LLC · 2015 · 2 generations on7descendants
  • K132910Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC · 2013 · 2 generations on4descendants
  • K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc. · 2014 · 3 generations on3descendants
  • K201662REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc. · 2020 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030302HBS Headless Bone ScrewSchoening & Assoc., Inc.2003—
+1K112672Headless Compression ScrewSkeletal Dynamics, LLC2011—
+2K143624Headless Compression Screw SystemSkeletal Dynamics, LLC2015—
+2K132910Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC2013—
+3K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc.2014—
+3K201662REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
201410
201510
201810
201910
202010
202210
202310
202510
202620
FIG. 1 — Lineage of K030302, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 22.3 · 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K112672Headless Compression ScrewSkeletal Dynamics, LLC201110
K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH20180

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?

  • Of its descendants, K112672 (Skeletal Dynamics, LLC, 2011) has gone furthest, with 10 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Headless bone screw system for the fixation of osseous fragments or fractures including: HBS - MINI Scaphoid fractures Lunate fractures Capitate Trapezial fractures Metacarpal and metatarsal fractures Phalangeal fractures Radial head fractures Ulnar styloid fractures Osteo-chrondral Small joint fusions HBS - STANDARD Scaphoid fractures Carpal fractures & non-unions Capitellum fractures Metacarpal fractures Phalangeal fractures Distal radial fractures…

Read the full statement (89 words)

Headless bone screw system for the fixation of osseous fragments or fractures including:

HBS - MINI

Scaphoid fractures

Lunate fractures

Capitate

Trapezial fractures

Metacarpal and metatarsal fractures

Phalangeal fractures

Radial head fractures

Ulnar styloid fractures

Osteo-chrondral

Small joint fusions

HBS - STANDARD

Scaphoid fractures

Carpal fractures & non-unions

Capitellum fractures

Metacarpal fractures

Phalangeal fractures

Distal radial fractures

Radial head fractures

Ulnar styloid fractures

Small joint fusions

Humeral head fractures

Glenoid fractures

Intercarpal fusions

Interphalangeal fractures

Metatarsal osteotomies

Tarsal fusions

Malleolar fractures

Patellar fractures

Osteo-chrondral fractures

Odontoid fractures

Mandibular fractures

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in HWC

The HWC category page

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https://510kreport.com/device/K030302 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030302: HBS Headless Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030302

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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