510(k) · Cleared
ClearedOdi 7.0MM Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Designs, Inc. · HTN Washer, Bolt Nut
Cleared on Apr 1, 2003 as substantially equivalent to K990776 (Aap Implantate AG, 1999) and 3 other predicates after a 33-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Apr 1, 2003
- Review
- 33 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K893512 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK893512 Depuy Cannulated Bone ScrewDepuy, Inc. · 1989
- This deviceK030619 Odi 7.0MM Cannulated Screw SystemOrthopedic Designs, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893512 | Depuy Cannulated Bone Screw | Depuy, Inc. | 1989 | — |
| 0 (this device) | K030619 | Odi 7.0MM Cannulated Screw System | Orthopedic Designs, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 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 HTN? 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? (5)
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 |
|---|---|---|---|
| * | K990776 | Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MMSummary page 2…lization. Within the proposed class, the following devices are used as predicate devices for comparison: aaP Implants, Inc I K990776 AlDhatec Mfa.. Inc I -NA- Advanced O>hopaedic… | 1999 |
| * | K014185 | Aos Cannulated Bone Screw System | 2002 |
| * | K893512 | Depuy Cannulated Bone ScrewSummary page 2…Advanced O>hopaedic Orthopaedic Solutions KO14185 DePuy/ACE, Inc. K893512 Magly Orthopedics, LLC KO21662 Each of these products are commercially available… | 1989 |
| * | K021662 | Magly 6.5MM Cannulated Screws | 2002 |
| * | — | AlDhatec Mfa.. Inc Named without a submission number |
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?
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K990776.
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 ODi 7.0mm Cannulated Screw System will be used on indications that are common with presently marketed cannulated screw systems. The primary indications are for fixation/stabilization of stable fractures of the proximal femur including pertrochanteric fractures, basilar femoral neck fractures, subcapital femoral fractures, and combinations of these fractures. Other indications include intercondylar femoral fractures and tibial plateau fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030619 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030619: Odi 7.0MM 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/K030619
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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