510(k) · Cleared
Recalled · 2006Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · HTN Washer, Bolt Nut
Cleared on Feb 8, 2001 after an 87-day review. The FDA summary names its predicate without a number. 1 of the 346 devices in its family, counting itself, has a Class I recall. 345 later devices descend from it. It has been recalled once.
- Decided
- Feb 8, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- HTN
- Recalls
- 1
- Predicates
- 0
345 later devices descend from it, 6 citing it directly. 1 of the 346 devices in this family, counting this one, has a Class I recall.
- This deviceK003496 Cannulated Screw SystemPioneer Surgical Technology · 2001
- Descendant · cites it directly · 309 of its ownK102903 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 · 135 of its ownK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 133 of its ownK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- Descendant · 2 generations on · 92 of its ownK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
Showing 5 of 345 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 345 · See all- K102903Pioneer Cannulated Screw SystemPioneer Surgical Technology, Inc. · 2010 · cites it directly309descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · cites it directly161descendants
- K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · cites it directly135descendants
- K131405Ifuse Implant SystemSI-BONE, Inc. · 2013 · 2 generations on133descendants
- K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012 · 2 generations on92descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003496 | Cannulated Screw System | Pioneer Surgical Technology | 2001 | — |
| +1 | K102903 | Pioneer Cannulated Screw System | Pioneer Surgical Technology, Inc. | 2010 | — |
| +1 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +1 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| +2 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| +2 | K110472 | SI-Fix Sacroiliac Joint Fusion System | Medtronic Sofamor Danek | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 20 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 7 | 0 |
| 2019 | 16 | 0 |
| 2020 | 22 | 0 |
| 2021 | 23 | 1 |
| 2022 | 32 | 0 |
| 2023 | 42 | 0 |
| 2024 | 45 | 0 |
| 2025 | 44 | 0 |
| 2026 | 48 | 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.5 · 6 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 |
|---|---|---|---|
| * | — | Zimmer Magna-FX Named without a submission number | |
| * | — | ZIMMER Mini MAGNA-FX Named without a submission number | |
| * | — | Synthes Cannulated Screw System Named without a submission number |
What descends from it? (345)
See all 3456 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102903 | Pioneer Cannulated Screw System | 2010 | 309 |
| K111994 | Smith & Nephew Cannulated Screws and Washers | 2011 | 161 |
| K112885 | Zimmer Plates and Screws System Screws Only | 2011 | 135 |
| K060156 | Straight Plate with Angular Stability & Screw System | 2006 | 27 |
| K150693 | PHIN-FX Cannulated Lag Screw System | 2015 | 9 |
| K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate System | 2011 | 7 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2006 | Not classified | Z-0872-06 | Other | There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended. |
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?
- Of its descendants, K102903 (Pioneer Surgical Technology, Inc., 2010) has gone furthest, with 309 descendants of its own.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 1 | — | 0 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
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: 1. Fractures of the tarsals and metatarsals; 2. Metatarsal and phalangeal osteotomies; 3. Fractures of the carpals and metacarpals; 4. Carpal and metacarpal arthrodesis; 5. Small fragments of the hand and wrist; 6. Ligament fixation as appropriate; 7. Sacroiliac joint disruptions; 8. Fractures of the distal femur and…
Read the full statement (117 words)
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
1. Fractures of the tarsals and metatarsals;
2. Metatarsal and phalangeal osteotomies;
3. Fractures of the carpals and metacarpals;
4. Carpal and metacarpal arthrodesis;
5. Small fragments of the hand and wrist;
6. Ligament fixation as appropriate;
7. Sacroiliac joint disruptions;
8. Fractures of the distal femur and proximal tibia;
9. Intracapsular fractures of the hip;
10. Ankle arthrodesis; and
11. Pelvis and acetabulum fractures;
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/K003496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003496: Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003496
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026