510(k) Report

510(k) · Cleared

Cleared

HBS2 Headless Bone Screw

K171628510(k) TraditionalCleared Jan 12, 2018224-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

Stuckenbrock Medizintechnik GmbH · HWC Screw, Fixation, Bone

Cleared on Jan 12, 2018 as substantially equivalent to K030302 (Schoening & Assoc., Inc., 2003) and 2 other predicates after a 224-day review. Its family tree reaches back 1 generation to 2002.

Decided
Jan 12, 2018
Review
224 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K021556 (2002). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2003: 1 other ancestorK021556 · Synthes 2.4 MM Cannulated Compression Screw · Synthes (Usa) · 200220002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors K021556 · Synthes 2.4 MM Cannulated Compression Screw · Synthes (Usa) · 20020
  1. Root · 1 generation backK021556 Synthes 2.4 MM Cannulated Compression ScrewSynthes (Usa) · 2002
  2. This deviceK171628 HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K021556Synthes 2.4 MM Cannulated Compression ScrewSynthes (Usa)2002—
0 (this device)K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
FIG. 1 — Lineage of K171628, 2002–2018Source: 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 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. #1 K203011 Monster Screw Systemscore 22.2 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K030302HBS Headless Bone Screw
Summary page 8
…K171628 Page 5/6 510(K) HBS2 Headless Bone Screw 4. Predicate Devices 4.1. Primary Predicate Device  HBS HEADLESS BONE SCREW, SCHOENING & ASSOC., INC., K030302 4.2. Secondary Predicate or Reference Devices  SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW, SYNTHES (USA), K021556  SYNT…
Schoening & Assoc., Inc.2003—
*K021556Synthes 2.4 MM Cannulated Compression Screw
Summary page 8
…BS HEADLESS BONE SCREW, SCHOENING & ASSOC., INC., K030302 4.2. Secondary Predicate or Reference Devices  SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW, SYNTHES (USA), K021556  SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS, SYNTHES (USA), K050636 4.2.1. Substantial Equivalence Claimed to predicate Device…
Synthes (Usa)2002—
*K050636Synthes 3.0MM Headless Compression Screws
Summary page 8
…ry Predicate or Reference Devices  SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW, SYNTHES (USA), K021556  SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS, SYNTHES (USA), K050636 4.2.1. Substantial Equivalence Claimed to predicate Devices The Stuckenbrock HBS2 headless bone screws are substantially equivale…
Synthes (Usa)20051

Also cleared against K030302: 1 other device →

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?

  • 1 of the 3 ancestors has a recall of any class.
  • 1 other device also cites its predicate K030302.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

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?

HBS2 Headless Bone Screw is used for the treatment of intraarticular and extraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of: HBS2 MIDI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures, Fractures of the processus styloideus ulnae, Proximal radial head…

Read the full statement (95 words)

HBS2 Headless Bone Screw is used for the treatment of intraarticular and extraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of:

HBS2 MIDI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures

HBS2 MINI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures, Fractures of the processus styloideus radii

Indications for use as stated in the FDA summary.

Also cleared against K030302

1 other device cites the same predicate.

  • K112672Headless Compression ScrewSkeletal Dynamics, LLC · 2011

More from Stuckenbrock Medizintechnik GmbH

3 FDA decisions under this applicant name. See the company

  • K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH · 2018
  • K042902Herbert Ulnar Head Prosthesis SystemStuckenbrock Medizintechnik GmbH · 2004

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
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https://510kreport.com/device/K171628 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171628: HBS2 Headless Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171628

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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