510(k) · Cleared
ClearedActive Screw Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Implant Systems, LLC · HWC Screw, Fixation, Bone
Cleared on Oct 4, 2012 as substantially equivalent to K961157 (Whiteside Biomechanics, Inc., 1996) and 3 other predicates after a 119-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- Oct 4, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K082320 (2008). 6 ancestors in all, the oldest K961157 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
- 2 generations backK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · Recalled
- 1 generation backK112772 Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011
- This deviceK121682 Active Screw Bone ScrewIntelligent Implant Systems, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K082320 | Darco Small Screw | Wrightmedicaltechnologyinc | 2008 | — |
| −2 | K102429 | Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw | Wrightmedicaltechnologyinc | 2010 | 1 |
| −1 | K112772 | Ortholoc (TM) Bone Screws | Wrightmedicaltechnologyinc | 2011 | — |
| 0 (this device) | K121682 | Active Screw Bone Screw | Intelligent Implant Systems, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K961157 | Whiteside Biomechanics Cancellous Bone ScrewSummary page 1…tion: 21 CFR 888.3040 - Class 11 Device Product Code: HWC: Screw, Fixation Bone 87 Orthopedics Predicate Devices: K961 157 - Whiteside Riomnechanics Cancellous Bone Screw, K 102429, KI 12772 - Wright Medical Technology… | 1996 |
| * | K102429 | Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewSummary page 1…Fixation Bone 87 Orthopedics Predicate Devices: K961 157 - Whiteside Riomnechanics Cancellous Bone Screw, K 102429, KI 12772 - Wright Medical Technology ORTHOLOCTM Bone Screws, K061621 - Synthes (USA)… | 2010 |
| * | K112772 | Ortholoc (TM) Bone Screws | 2011 |
| * | K061621 | Synthes (Usa) 6.5 MM Cancellous ScrewsSummary page 1…iteside Riomnechanics Cancellous Bone Screw, K 102429, KI 12772 - Wright Medical Technology ORTHOLOCTM Bone Screws, K061621 - Synthes (USA) 6.5 mm Cancellous Screws Device Description: The ACTIVE TM Screw Bone… | 2006 |
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 4 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The ACTIVETM Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121682: Active Screw Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121682
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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