510(k) · Cleared
ClearedWisorb Malleolar Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cambridge Scientific, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 29, 2002 as substantially equivalent to K952471 (Bioscience, Inc., 1995) and 2 other predicates after a 188-day review. Its family tree reaches back 2 generations to 1979. 2 later devices descend from it.
- Decided
- Jul 29, 2002
- Review
- 188 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792022 (1979). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 1 generation backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- This deviceK020222 Wisorb Malleolar ScrewCambridge Scientific, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK040265 Little Grafter ScrewBiocomposites, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK073312 Osteotrans-OT ScrewTakiron Co., Ltd. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −1 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| 0 (this device) | K020222 | Wisorb Malleolar Screw | Cambridge Scientific, Inc. | 2002 | — |
| +1 | K040265 | Little Grafter Screw | Biocomposites, Ltd. | 2004 | — |
| +1 | K073312 | Osteotrans-OT Screw | Takiron Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K952471 | Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation RodSummary page 1…n Screw. Predicate Devices: 1. BiofM3 Bioabsorbable Self-reinforced Poly-L-Lactide, Fixation Threaded Rod (K952471) 2. Biofixa BioabsorbablePoly(Glyco1icAcid), Thr… | 1995 |
| * | K920188 | Threaded PinsSummary page 1…ixation Threaded Rod (K952471) 2. Biofixa BioabsorbablePoly(Glyco1icAcid), Threaded Rod (K920 188) 3. Biofixa Bioabsorbable Distal Radial Screw (K974876) Int nded Uses:… | 1993 |
| * | K974876 | Bionx Distal Radius ScrewSummary page 1…oly(Glyco1icAcid), Threaded Rod (K920 188) 3. Biofixa Bioabsorbable Distal Radial Screw (K974876) Int nded Uses: The WISORBTMmalleolar screw is intended for use in bone-to-bone… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K040265 (Biocomposites, Ltd., 2004) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K952471.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 WISORBm malleolar screw is intended for use in bone-to-bone fixation in the metaphyseal area, distal humerous, trochanteric area and in the ankle where the bone is dense. The WISORBm malleolar screw is intended primarily for internal fixation of fractures with minimal displacement commonly seen in fractures of the ankle and foot, such as, transverse fibular fractures at or distal to the ankle joint (Danis-Weber Type A); low spiral fractures of the…
Read the full statement (157 words)
The WISORBm malleolar screw is intended for use in bone-to-bone fixation in the metaphyseal area, distal humerous, trochanteric area and in the ankle where the bone is dense.
The WISORBm malleolar screw is intended primarily for internal fixation of fractures with minimal displacement commonly seen in fractures of the ankle and foot, such as, transverse fibular fractures at or distal to the ankle joint (Danis-Weber Type A); low spiral fractures of the lateral malleolus, avulsion fractures of the medial malleolus (Dyputren; Dank-Weber Type-B), avulsion fractures of the posterior malleolus (Volkmann’s Triangle). Other fractures that maybe suitable for treatment with the WISORBTMmalleolar screw include distal radial fractures (Type Colles), which typically occur at the metaphyseal portion of the bone proximal to the extensor tendon sheaths.
The WISORBm malleolar screw is not intended for use in and is contraindicated for:
Fractures of cortical bone (diaphyseal area)
Situations of active or potential infection or where patient cooperation cannot be guaranteed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020222: Wisorb Malleolar Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020222
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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