510(k) · Cleared
ClearedI.B.S. osteosynthesis screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · HWC Screw, Fixation, Bone
Cleared on May 10, 2017 as substantially equivalent to K052576 (Small Bone Innovations, LLC, 2005) and 4 other predicates after a 71-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- May 10, 2017
- Review
- 71 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K962823 (1996). 30 ancestors in all, the oldest K903810 (1990). 1 later device descends from it, 1 citing it directly.
- 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 backK011821 Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
- 4 generations backK050346 Stabilization ScrewNew Deal, S.A. · 2005 · Recalled
- 3 generations backK071639 Qwix Positioning ScrewNewdeal Sas · 2007 · Recalled
- 2 generations backK131920 Stabilization ScrewIn2bones Sas · 2014 · Recalled
- 1 generation backK160174 I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 2016
- This deviceK170594 I.B.S. osteosynthesis screwsIn2bones Sas · 2017
- Descendant · cites it directly · 0 of its ownK254280 F.A.S.T ScrewSteps Ortho · 2026
Most influential descendants
Showing 1 of 1 · See all- K254280F.A.S.T ScrewSteps Ortho · 2026 · cites it directly0descendants
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 | K011821 | Modification to the I.C.O.S Screw | New Deal, S.A. | 2001 | — |
| −4 | K050346 | Stabilization Screw | New Deal, S.A. | 2005 | 4 |
| −3 | K071639 | Qwix Positioning Screw | Newdeal Sas | 2007 | 1 |
| −2 | K131920 | Stabilization Screw | In2bones Sas | 2014 | 3 |
| −1 | K160174 | I.B.S. 2.0 Osteosynthesis screw | In2bones Sas | 2016 | — |
| 0 (this device) | K170594 | I.B.S. osteosynthesis screws | In2bones Sas | 2017 | — |
| +1 | K254280 | F.A.S.T Screw | Steps Ortho | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K052576 | Sbi AutofixSummary page 5…tion of length 30mm, and creation of dedicated references. Predicate Devices Compression design: x SBI, Autofix (K052576) x Biomet Trauma, BioDrive Cannulated screw system (K082874)… | 2005 |
| * | K082874 | Biodrive Cannulated Screw SystemSummary page 5…Compression design: x SBI, Autofix (K052576) x Biomet Trauma, BioDrive Cannulated screw system (K082874) x In2Bones, I.B.S.™ 2.0 Osteosynthesis screw (K160174)… | 2009 |
| * | K160174 | I.B.S. 2.0 Osteosynthesis screwSummary page 5…uma, BioDrive Cannulated screw system (K082874) x In2Bones, I.B.S.™ 2.0 Osteosynthesis screw (K160174) x In2Bones, I.B.S.™ Osteosynthesis screw (K131920) Ne… | 2016 |
| * | K131920 | Stabilization ScrewSummary page 4…esis Screw Silver Spring, MD 20906 Phone: 240-994-9999 Email: [email protected] Initial 510(k) number K131920 Proprietary Name I.B.S.™ osteosynthesis screws Common name Bone fixation screw Device classification 2… | 2014 |
| * | K944330 | Acutrak Plus Fixation SystemSummary page 5…Bones, I.B.S.™ Osteosynthesis screw (K131920) Neutralization design: x Acumed, Acutrak screws (K944330) x Biomet Trauma, BioDrive Cannulated screw system (K082874)… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254280 | F.A.S.T Screw | 2026 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 30 ancestors have a recall of any class.
- Of its descendants, K254280 (Steps Ortho, 2026) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K052576.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 1.B.S.™ compression and neutralization osteosynthesis screws are intended for:
- The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs
- Osteosynthesis requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
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/K170594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170594: I.B.S. osteosynthesis screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170594
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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