510(k) · Cleared
ClearedOrthoflex Rod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Pro, LLC · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on Jan 14, 2011 as substantially equivalent to K022886 (Osteomed Corp., 2002) and 3 other predicates after a 127-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jan 14, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K884739 (1989). 5 ancestors in all, the oldest K801094 (1980). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884739 | Sgarlato Lesser Toe Implant | Sgarlato Laboratories, Inc. | 1989 | — |
| −1 | K022886 | Metatarsophalangeal Flexible Stabilizing Rod System | Osteomed Corp. | 2002 | — |
| 0 (this device) | K102601 | Orthoflex Rod | Ortho-Pro, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 2002 | 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 KWH? 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 KWH device
- #1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K022886 | Metatarsophalangeal Flexible Stabilizing Rod SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * Metatarsophalangeal and Interphalangeal - K022886/ K022887 (OsteoMed) * Shaw-Ship Rod - K905795 (Sgarlato Laboratories) * Swanson Hammertoe Implant - K801094… | 2002 |
| * | K022887 | Interphalangeal Flexible Stabilizing Rod SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * Metatarsophalangeal and Interphalangeal - K022886/ K022887 (OsteoMed) * Shaw-Ship Rod - K905795 (Sgarlato Laboratories) * Swanson Hammertoe Implant - K801094 (Wright… | 2002 |
| * | K905795 | Sgarlato Flexible Hinge Toe ImplantSummary page 1…gally marketed devices which are substantially equivalent: * Metatarsophalangeal and Interphalangeal - K022886/ K022887 (OsteoMed) * Shaw-Ship Rod - K905795 (Sgarlato Laboratories) * Swanson Hammertoe Implant - K801094 (Wright Medical Technology) 4. Description of the devic… | 1991 |
| * | K801094 | Silastic Hammertoe Implant (Swanson-WellSummary page 1…tatarsophalangeal and Interphalangeal - K022886/ K022887 (OsteoMed) * Shaw-Ship Rod - K905795 (Sgarlato Laboratories) * Swanson Hammertoe Implant - K801094 (Wright Medical Technology) 4. Description of the device: The Ortholex Rod design is a double-stemmed flexible implant des… | 1980 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K022886.
How does its category compare?
All KWH devicesKWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KWH
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KWH
Too few KWH 510(k)s in any year since 2007 to give a median.
Recalls per year · KWH
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWH
8in 2025
MAUDE reports naming product code KWH, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indications for the Ortholex Rod include:
* Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
* Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
* Revision of a failed arthroplasty or arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102601: Orthoflex Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102601
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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