510(k) · Cleared
Recalled · Class II · 2017OrthoSolutions 'System26' Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Solutions UK Limited · HWC Screw, Fixation, Bone
Cleared on Mar 8, 2017 as substantially equivalent to K110895 (Ortho Solutions Limited, 2011) and 5 other predicates after an 86-day review. Its family tree reaches back 12 generations to 1996. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 8, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 12 generations to K962616 (1996). 200 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 1 generation backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- This deviceK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017
- Descendant · cites it directly · 1 of its ownK203773 BRM TOOL ScrewsBrm Extremities Srl · 2022
- Descendant · cites it directly · 0 of its ownK231649 Intraosseous Fusion Device SystemAuxano Medical, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK222820 BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 1 generation backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- This deviceK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −2 | K142442 | Magna-FX and Mini Magna-FX Cannulated Screw Fixation System | Zimmer, Inc. | 2014 | 3 |
| −1 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
| 0 (this device) | K163489 | OrthoSolutions 'System26' Bone Screws | Ortho Solutions UK Limited | 2017 | — |
| +1 | K203773 | BRM TOOL Screws | Brm Extremities Srl | 2022 | — |
| +1 | K231649 | Intraosseous Fusion Device System | Auxano Medical, LLC | 2023 | — |
| +2 | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 18 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 17 | 0 |
| 2006 | 13 | 0 |
| 2007 | 8 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K110895 | Ortho Solutions Trauma Implants for OsteosynthesisSummary page 4…DEVICE PRODUCT CODE: HWC SUBSEQUENT PRODUCT CODE: HTN SUBSTANTIALLY OrthoSolutions - Cannulated Bone Screws & Washers (K110895) EQUIVALENT DEVICES OrthoSolutions – TwistFix & Compression Screws (K111678) Vilex - Cannulated… | 2011 |
| * | K111678 | Ortho Solutions Extremity Fixation Implants for OsteosysnthesisSummary page 4…HTN SUBSTANTIALLY OrthoSolutions - Cannulated Bone Screws & Washers (K110895) EQUIVALENT DEVICES OrthoSolutions – TwistFix & Compression Screws (K111678) Vilex - Cannulated Bone Screws (K991197, K014154) Ascent Medical – Cannulate… | 2012 |
| * | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…Summary page 4…e Screws & Washers (K110895) EQUIVALENT DEVICES OrthoSolutions – TwistFix & Compression Screws (K111678) Vilex - Cannulated Bone Screws (K991197, K014154) Ascent Medical – Cannulated Bone Screws & Washers (K150693) I.T.S.… | 1999 |
| * | K014154 | Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…Summary page 4…& Washers (K110895) EQUIVALENT DEVICES OrthoSolutions – TwistFix & Compression Screws (K111678) Vilex - Cannulated Bone Screws (K991197, K014154) Ascent Medical – Cannulated Bone Screws & Washers (K150693) I.T.S. GmbH – HC… | 2002 |
| * | K150693 | PHIN-FX Cannulated Lag Screw SystemSummary page 4…Screws (K111678) Vilex - Cannulated Bone Screws (K991197, K014154) Ascent Medical – Cannulated Bone Screws & Washers (K150693) I.T.S. GmbH – HCS Compression Screw (K131722) OrthoSolutions ‘System26’ Bone Screws… | 2015 |
| * | K131722 | I.T.S. Extremity Fixation SystemsSummary page 4…s (K991197, K014154) Ascent Medical – Cannulated Bone Screws & Washers (K150693) I.T.S. GmbH – HCS Compression Screw (K131722) OrthoSolutions ‘System26’ Bone Screws Page 1 of 3 Section XII… | 2013 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2017 | Class II | Z-0967-2018 | Process control | Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 35 of the 200 ancestors have a recall of any class.
- Of its descendants, K203773 (Brm Extremities Srl, 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K110895.
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 OrthoSolutions ‘System26’ cannulated screws (headed and headless compression) and washers are indicated for use over a guide pin or wire for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. Washers of matching size to the headed cannulated bone screw may be used in certain applications for deficient osteopenic bone. The non-cannulated 2.0 (headed, headless…
Read the full statement (294 words)
The OrthoSolutions ‘System26’ cannulated screws (headed and headless compression) and washers are indicated for use over a guide pin or wire for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. Washers of matching size to the headed cannulated bone screw may be used in certain applications for deficient osteopenic bone. The non-cannulated 2.0 (headed, headless compression and Twist-Off) bone screws are applicable, as well, for bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
‘System26’ non-cannulated 2.0mm (headed, headless compression and Twist-Off) bone screws and cannulated (headed and headless compression) bone screw sizes of 2.0mm, 2.5mm 3.0mm are indicated for treating small bone fractures as well as performing osteotomies, arthrodesis and joining cancellous bone fragments in the upper and lower limb and extremities.
‘System26’ cannulated bone screw sizes (headless compression and headed with optional matching washer) of 4.0mm, 5.0mm, 6.5mm, and 8.0mm are indicated to be used with large and long bones. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive bone fracture/joint reconstructions; Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus; Fractures of the tibia; Cooper fractures of the tibia; Bone fractures of the radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Bone fractures of the acetabulum and dorsal pelvic ring; Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Bone fractures of the calcaneus and talus; Arthrodesis of the ankle joint; Arthrodesis of foot joints and; Avulsion fractures.
The OrthoSolutions 'System26' Bone Screws are not intended for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163489: OrthoSolutions 'System26' Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163489
Report an extraction error
Are you the manufacturer?
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