510(k) · Cleared
ClearedPioneer Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · HWC Screw, Fixation, Bone
Cleared on Oct 20, 2010 as substantially equivalent to K003496 (Pioneer Surgical Technology, 2001) and 2 other predicates after a 20-day review. Its family tree reaches back 1 generation to 1996. 1 of the 313 devices in its family, counting itself, has a Class I recall. 309 later devices descend from it.
- Decided
- Oct 20, 2010
- Review
- 20 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K962011 (1996). 3 ancestors in all. 309 later devices descend from it, 10 citing it directly. 1 of the 313 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK962011 Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa) · 1996
- This deviceK102903 Pioneer Cannulated Screw SystemPioneer Surgical Technology, Inc. · 2010
- Descendant · cites it directly · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 133 of its ownK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- Descendant · cites it directly · 92 of its ownK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
- Descendant · 2 generations on · 88 of its ownK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- Descendant · 2 generations on · 86 of its ownK150875 iFuse Implant SystemSI-BONE, Inc. · 2015
Showing 5 of 309 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 309 · See all- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · cites it directly161descendants
- K131405Ifuse Implant SystemSI-BONE, Inc. · 2013 · cites it directly133descendants
- K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012 · cites it directly92descendants
- K141049Ifuse Implant SystemSI-BONE, Inc. · 2014 · 2 generations on88descendants
- K150875iFuse Implant SystemSI-BONE, Inc. · 2015 · 2 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962011 | Synthes 7.0/7.3 MM Cannulated Screws | Synthes (Usa) | 1996 | — |
| 0 (this device) | K102903 | Pioneer Cannulated Screw System | Pioneer Surgical Technology, Inc. | 2010 | — |
| +1 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +1 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| +1 | K110472 | SI-Fix Sacroiliac Joint Fusion System | Medtronic Sofamor Danek | 2012 | — |
| +2 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| +2 | K150875 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 14 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 6 | 0 |
| 2019 | 15 | 0 |
| 2020 | 18 | 0 |
| 2021 | 23 | 1 |
| 2022 | 31 | 0 |
| 2023 | 42 | 0 |
| 2024 | 44 | 0 |
| 2025 | 41 | 0 |
| 2026 | 44 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K003496 | Cannulated Screw SystemSummary page 1…8.3030: Single/multiple component metallic bone fixation appliances and accessories Product Code: HWC: Screw, Fixation, and HTN: washer, bolt nut The Panel code is 87. K003496 — Pioneer Cannulated Screw System (SE 02/08/2001) K021932 — Synthes 6.5mm Cannulated Screw (SE 9/6/2002) K962011 — Synthes 7.0/7.… | 2001 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 1…ppliances and accessories Product Code: HWC: Screw, Fixation, and HTN: washer, bolt nut The Panel code is 87. K003496 — Pioneer Cannulated Screw System (SE 02/08/2001) K021932 — Synthes 6.5mm Cannulated Screw (SE 9/6/2002) K962011 — Synthes 7.0/7.3mm Cannulated Screw (SE 8/5/1996) The Cannulated Screw S… | 2002 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 1…xation, and HTN: washer, bolt nut The Panel code is 87. K003496 — Pioneer Cannulated Screw System (SE 02/08/2001) K021932 — Synthes 6.5mm Cannulated Screw (SE 9/6/2002) K962011 — Synthes 7.0/7.3mm Cannulated Screw (SE 8/5/1996) The Cannulated Screw System by Pioneer consists of cannulated screws of varyi… | 1996 |
What descends from it? (309)
See all 30910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111994 | Smith & Nephew Cannulated Screws and Washers | 2011 | 161 |
| K131405 | Ifuse Implant System | 2013 | 133 |
| K110472 | SI-Fix Sacroiliac Joint Fusion System | 2012 | 92 |
| K143039 | CrossRoads Screw System | 2015 | 79 |
| K141549 | SImmetry Sacroiliac Joint Fusion System | 2015 | 63 |
| K124027 | Monster Screw System | 2013 | 41 |
| K123890 | Acumed Cannulated Screw System | 2013 | 36 |
| K150693 | PHIN-FX Cannulated Lag Screw System | 2015 | 9 |
| K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | 2011 | 8 |
| K181610 | ActivOrtho Nitinol Compression Screw System | 2019 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following: Fractures of the tarsals and metatarsals; Metatarsal and phalangeal osteotomies; Fractures of the carpals and metacarpals; Carpal and metacarpal arthrodesis; Small fragments of the hand and wrist; Ligament fixation, if appropriate; Sacroiliac joint disruptions; Fractures of the distal femur and proximal tibia…
Read the full statement (114 words)
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
Fractures of the tarsals and metatarsals;
Metatarsal and phalangeal osteotomies;
Fractures of the carpals and metacarpals;
Carpal and metacarpal arthrodesis;
Small fragments of the hand and wrist;
Ligament fixation, if appropriate;
Sacroiliac joint disruptions;
Fractures of the distal femur and proximal tibia;
Intracapsular fractures of the hip;
Ankle arthrodesis; and
Pelvis and acetabulum fractures; and
Areas where accurate screw placement Is vital.
This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.
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/K102903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102903: Pioneer Cannulated 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/K102903
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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