510(k) · Cleared
Recalled · Class II · 2022Acumed Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumed, LLC · HWC Screw, Fixation, Bone
Cleared on Mar 18, 2013 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 5 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1996. 36 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 18, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 7 generations to K962823 (1996). 53 ancestors in all, the oldest K792022 (1979). 36 later devices descend from it, 6 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 backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 4 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 3 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 2 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 1 generation backK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- This deviceK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013
- Descendant · cites it directly · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- Descendant · 2 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · cites it directly · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- Descendant · 3 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- Descendant · 2 generations on · 6 of its ownK203011 Monster Screw SystemParagon 28, Inc. · 2020
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · cites it directly21descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 2 generations on9descendants
- K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · cites it directly9descendants
- K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 3 generations on8descendants
- K203011Monster Screw SystemParagon 28, Inc. · 2020 · 2 generations on6descendants
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 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −4 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −3 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −2 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −1 | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | 1 |
| 0 (this device) | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | — |
| +1 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| +2 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +1 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
| +3 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| +2 | K203011 | Monster Screw System | Paragon 28, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 1…itanium Headed and Headless Screw Set, and the Pioneer Cannulated Screw System. 510(k) Number Product Code Trade Name Applicant K021932 HWC, OUR Synthes 6.5 mm Cannulated Screw Synthes (USA) 888.3040 K962011I… | 2002 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 1…Name Applicant K021932 HWC, OUR Synthes 6.5 mm Cannulated Screw Synthes (USA) 888.3040 K962011I HWC Synthes 7.0/7.3 mm Cannulated Synthes (USA) 888.3040 Scr… | 1996 |
| * | K111316 | Aap Cannulated ScrewsSummary page 1…888.3040 K962011I HWC Synthes 7.0/7.3 mm Cannulated Synthes (USA) 888.3040 Screws KI 111316 HWC aap Cannulated Screw aap Implantate AG 888.3040… | 2011 |
| * | K983165 | Osteo 4.0MM Cannulated Screw SystemSummary page 1…HWC aap Cannulated Screw aap Implantate AG 888.3040 __________ K983 165 HWC Osteo 4.0mm Cannulated Screw Osteonics Corporation 888.3040… | 1998 |
| * | K120493 | Mini Cannulated Headed and Headless Screw SetSummary page 1…HWC Osteo 4.0mm Cannulated Screw Osteonics Corporation 888.3040 System __________ K120493 HWC Mini Cannulated Titanium Headed Instratek, Inc. 888.3040 a… | 2012 |
| * | K102903 | Pioneer Cannulated Screw SystemSummary page 1…________ K120493 HWC Mini Cannulated Titanium Headed Instratek, Inc. 888.3040 and Headless Screw Set K102903 HWC, OUR Pioneer Cannulated Screw System Pioneer Surgical ___________888.3040… | 2010 |
What descends from it? (36)
See all 366 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2022 | Class II | Z-0958-2022 | Device Design | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or… |
| Mar 9, 2022 | Class II | Z-0959-2022 | Device Design | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 53 ancestors have a recall of any class.
- Of its descendants, K190586 (Paragon 28, Inc., 2019) has gone furthest, with 21 descendants of its own.
- 61 other devices also cite its predicate K021932.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Acumed Cannulated Screw System consists of screws, washers, and accessories and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for size of device, which may include the following: Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures; Simple metaphyseal fractures; Fractures of the wrist, ankle, elbow…
Read the full statement (281 words)
The Acumed Cannulated Screw System consists of screws, washers, and accessories and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for size of device, which may include the following: Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures; Simple metaphyseal fractures; Fractures of the wrist, ankle, elbow, and shoulder; Condylar fractures; Epiphyseal and metaphyseal fractures in children; Osteochrondritis dissecans; Ostero-Chondral Fractures; Ligament avulsion injuries; Ligament fixation; Other small fragment, cancellous bone fractures; Small joint fusion; Areas where accurate screw placement is vital; Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures; Subtalar arthrodesis; Ankle arthrodesis; Fractures of small joints, such as: Ankde fractures, Navicular fractures; Fractures of the fibula, malleolus, and calcaneus; Distal tibia and pilon fractures; Acetabular fractures; Other fractures of the pelvic ring; Sacroiliac joint disruptions; Fractures of the femoral head and neck; Supracondylar femoral fractures; Slipped capital femoral epiphyses; An adjunct to DHS in basilar neck fractures; Pediatric femoral neck fractures; Intercondylar femur fractures; Intracapsular fractures of th6 hip; Fractures of the distal femur and proximal tibia; Paellar fractures; Tibial plateau fractures; Small fragments of the hand and wrist; Fractures of the carpals and metacarpals; Carpal and metacarpal arthrodesis; Scaphoid fracture and other fractures of the hand; Phalangeal and interphalangeal fractures; Fractures of the ulna and radius; Radial head fractures; Fractures of the olecranon and distal humerus; Humeral head fractures; Ligament fixation at the proximal humerus; and Glenoid fractures. Washers may be used with the screws in certain applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123890: Acumed Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123890
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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