510(k) · Cleared
ClearedGso Bone Fixation Fasteners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gold Standard Orthopaedics, LLC · HWC Screw, Fixation, Bone
Cleared on Jan 31, 2007 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 4 other predicates after a 61-day review. Its family tree reaches back 5 generations to 1976. 4 later devices descend from it.
- Decided
- Jan 31, 2007
- Review
- 61 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K761228 (1976). 37 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 4 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 3 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 2 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 1 generation backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- This deviceK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007
- Descendant · cites it directly · 3 of its ownK071035 Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK130613 Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014
- Descendant · 3 generations on · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK140216 Orthopedic Fixation SystemsImpact Medical, LLC · 2014
Most influential descendants
Showing 4 of 4 · See all- K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007 · cites it directly3descendants
- K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014 · 2 generations on1descendant
- K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025 · 3 generations on0descendants
- K140216Orthopedic Fixation SystemsImpact Medical, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −4 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −1 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| 0 (this device) | K063589 | Gso Bone Fixation Fasteners | Gold Standard Orthopaedics, LLC | 2007 | — |
| +1 | K071035 | Ifs Bone Fixation Devices | Internal Fixation Systems, Inc. | 2007 | — |
| +2 | K130613 | Cannulated Screw and Kirschner (Kwire) System | Laura Cattabriga | 2014 | — |
| +3 | K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025 | — |
| +2 | K140216 | Orthopedic Fixation Systems | Impact Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K960385 | Sterile Kirschner Wires and Steinmann PinsSummary page 2…rial as the predicates: IFS Cannulated Bone Screw - Internal Fixation Systems, Inc. (K061620) and Sterile Kirschner Wires and Steinmann Pins - DePuy, Inc. (K960385). 10. Non-Clinical Testing: Non-clinical testing was not necessary to determine substantial equivalence between th… | 1996 |
| * | K011719 | Plus Cancellous Bone ScrewsSummary page 1…ntial Equivalence is claimed: * Sterile Kirschner Wires and Steinmann Pins - DePuy, Inc. (K(960385) * PLUS Cancellous Bone Screws - Plus Orthopedics (K01 1719) * BTI Cortical Bone Screws - Biodynamic Technologies, Inc. (K(972403) * IFS Cannulated Bone Screw - Internal… | 2001 |
| * | K972403 | Bti Cortical Bone ScrewsSummary page 2…inmann Pins - DePuy, Inc. (t<960385), PLUS Cancellous Bone Screws - Plus Orthopedics (K011719), and BTI Cortical Bone Screws - Biodynamic Technologies, Inc. (K972403), OsteoMed 1.2ram Auto-Drive Screw System - OsteoMed Corporation (K023260). They are manufactured from the same mat… | 1997 |
| * | K061620 | Ifs Cannulated Bone ScrewSummary page 2…steoMed Corporation (K023260). They are manufactured from the same material as the predicates: IFS Cannulated Bone Screw - Internal Fixation Systems, Inc. (K061620) and Sterile Kirschner Wires and Steinmann Pins - DePuy, Inc. (K960385). 10. Non-Clinical Testing: Non-clinical te… | 2006 |
| * | K023260 | 1.2MM Osteomed Auto-Drive Screw SystemSummary page 2…thopedics (K011719), and BTI Cortical Bone Screws - Biodynamic Technologies, Inc. (K972403), OsteoMed 1.2ram Auto-Drive Screw System - OsteoMed Corporation (K023260). They are manufactured from the same material as the predicates: IFS Cannulated Bone Screw - Internal Fixation Systems,… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071035 | Ifs Bone Fixation Devices | 2007 | 3 |
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 31 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 37 ancestors has a recall of any class.
- Of its descendants, K071035 (Internal Fixation Systems, Inc., 2007) has gone furthest, with 3 descendants of its own.
- 16 other devices also cite its predicate K960385.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 GSO Bone Fixation Fasteners are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Warning: GSO Bone Fixation Devices are not indicated for spinal fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063589: Gso Bone Fixation Fasteners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063589
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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