510(k) · Cleared
ClearedOsteoMed ExtremiFix Mid and Large Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed, LLC · HWC Screw, Fixation, Bone
Cleared on Apr 4, 2017 as substantially equivalent to K063298 (Osteomed LP, 2007) and 4 other predicates after a 133-day review. Its family tree reaches back 6 generations to 1996. 3 later devices descend from it.
- Decided
- Apr 4, 2017
- Review
- 133 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K962823 (1996). 23 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 3 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 2 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 1 generation backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- This deviceK163303 OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC · 2017
- Descendant · cites it directly · 1 of its ownK230744 Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK250251 Eleganz Fusion Screw System (Fusion Screw System)Dev4 · 2025
- Descendant · cites it directly · 0 of its ownK221333 Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR…Acumed, LLC · 2022 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC · 2023 · cites it directly1descendant
- K250251Eleganz Fusion Screw System (Fusion Screw System)Dev4 · 2025 · 2 generations on0descendants
- K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −2 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −1 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| 0 (this device) | K163303 | OsteoMed ExtremiFix Mid and Large Screw System | Osteomed, LLC | 2017 | — |
| +1 | K230744 | Acumed Acutrak 3 Headless Compression Screw System | Acumed, LLC | 2023 | — |
| +2 | K250251 | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | 2025 | — |
| +1 | K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | Acumed, LLC | 2022 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 4…Regulatory Class: II Product Code: HWC, HTN III. PREDICATE DEVICE Primary Predicate: OsteoMed Headless Cannulated Screw (K063298) Additional Predicate: OsteoMed Cannulated Screw System (K151021) Additional Predicate: Synthes Sterile 4… | 2007 |
| * | K151021 | OsteoMed Cannulated Screw SystemSummary page 4…I. PREDICATE DEVICE Primary Predicate: OsteoMed Headless Cannulated Screw (K063298) Additional Predicate: OsteoMed Cannulated Screw System (K151021) Additional Predicate: Synthes Sterile 4.5 mm Cannulated Screws (K963172) Additional Predicate: Smith & N… | 2015 |
| * | K963172 | Synthes Sterile 4.5 MM Cannulated ScrewsSummary page 4…Screw (K063298) Additional Predicate: OsteoMed Cannulated Screw System (K151021) Additional Predicate: Synthes Sterile 4.5 mm Cannulated Screws (K963172) Additional Predicate: Smith & Nephew Richards, Inc. Screw (K951389) Additional Predicate: OsteoMed Super… | 1996 |
| * | K951389 | Reunion Bone Screw SystemSummary page 4…tem (K151021) Additional Predicate: Synthes Sterile 4.5 mm Cannulated Screws (K963172) Additional Predicate: Smith & Nephew Richards, Inc. Screw (K951389) Additional Predicate: OsteoMed Super Screw System (K954330) Section 5: Page 1 of… | 1995 |
| * | K954330 | Super Screw 3.5 MMSummary page 4…annulated Screws (K963172) Additional Predicate: Smith & Nephew Richards, Inc. Screw (K951389) Additional Predicate: OsteoMed Super Screw System (K954330) Section 5: Page 1 of 6 OsteoMed ExtremiFix Mid & Large Screw System… | 1995 |
What descends from it? (3)
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?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K230744 (Acumed, LLC, 2023) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate K063298.
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 OsteoMed ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis,
and fracture fixation of foot, ankle, and long bones (upper and lower extremity). The screws are intended for single use
only. The system drills and guide wires are single use instruments.
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/K163303 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163303: OsteoMed ExtremiFix Mid and Large Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163303
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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