510(k) · Cleared
Recalled · 2006C-LEG (3C100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock Orthopedic Industry, Inc. · ISW Assembly, Knee/Shank/Ankle/Foot, External
Cleared on Jul 8, 1999 after a 62-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 8, 1999
- Review
- 62 days
- Class
- Class II
- Product code
- ISW
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991590 C-LEG (3C100)Otto Bock Orthopedic Industry, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK101859 Rel-K Artifical Limb ProsthesisRizzoli Ortopedica S.P.A. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101859Rel-K Artifical Limb ProsthesisRizzoli Ortopedica S.P.A. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991590 | C-LEG (3C100) | Otto Bock Orthopedic Industry, Inc. | 1999 | — |
| +1 | K101859 | Rel-K Artifical Limb Prosthesis | Rizzoli Ortopedica S.P.A. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 ISW? 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 |
|---|---|---|---|
| * | — | 3C1 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101859 | Rel-K Artifical Limb Prosthesis | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2006 | Not classified | Z-0363-2007 | Other | A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101859 (Rizzoli Ortopedica S.P.A., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ISW devicesISW Assembly, Knee/Shank/Ankle/Foot, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ISW
FDA has decided no ISW device since 2007.
Median 510(k) review, days · ISW
Too few ISW 510(k)s in any year since 2007 to give a median.
Recalls per year · ISW
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ISW
3in 2024
MAUDE reports naming product code ISW, 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 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 1 | 9 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Fitting of lower limb prosthesis
Highly mobile individuals and/or individuals who need stance stability
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/K991590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991590: C-LEG (3C100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991590
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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