510(k) · Cleared
ClearedOrtho Solutions - Sterile, Drills, Taps, Guide Pins & Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Solutions Limited · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Jan 20, 2011 as substantially equivalent to K962913 (Synthes (Usa), 1996) after a 120-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 20, 2011
- Review
- 120 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962913 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962913 Synthes Sterile Drill BitsSynthes (Usa) · 1996
- This deviceK102743 Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962913 | Synthes Sterile Drill Bits | Synthes (Usa) | 1996 | — |
| 0 (this device) | K102743 | Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires | Ortho Solutions Limited | 2011 | — |
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 HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K962913 | Synthes Sterile Drill BitsSummary page 1…c. 878.4820) DEVICE PRODUCT CODE: UWE SUBSEQUENT PRODUCT CODE: GFF, HSZ, GFA SUBSTANTIALLY Synthes Sterile Drill Bits (K(962913) EQUIVALENT DEVICES DEVICE DESCRIPTION: All Ortho Solutions Sterile Single-Use Drills Bits are manufactured… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K962913.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102743: Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102743
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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