510(k) · Cleared
Recalled · Class II · 2025Fixone Biocomposite Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aju Pharm Co., Ltd. · HWC Screw, Fixation, Bone
Cleared on Jan 5, 2021 as substantially equivalent to K032224 (Smith & Nephew, Inc., 2003) after a 385-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Jan 5, 2021
- Review
- 385 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915424 (1993). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 3 generations backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- 2 generations backK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
- 1 generation backK032224 Biorci ScrewSmith & Nephew, Inc. · 2003
- This deviceK193497 Fixone Biocomposite Interference ScrewAju Pharm Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK212912 OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors…B-One Ortho, Corp. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915424 | Arthrex Cannulated Interference Screw | Arthrex, Inc. | 1993 | — |
| −3 | K980841 | Rci Fixation Screws | Smith & Nephew, Inc. | 1998 | — |
| −2 | K992396 | Biorci Screw | Smith & Nephew Endoscopy, Inc. | 2000 | — |
| −1 | K032224 | Biorci Screw | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K193497 | Fixone Biocomposite Interference Screw | Aju Pharm Co., Ltd. | 2021 | — |
| +1 | K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All… | B-One Ortho, Corp. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K032224 | Biorci ScrewSummary page 4…WC 5) Regulation number : 888.3040 6) Class of device : Class II 7) Panel : Orthopedic 3. The legally marketed device to which we are claiming equivalence K032224, Smith&nephew, Inc. / Smith & Nephew BIORCI HA Screw 4. Device description The Fixone Biocomposite Interference Screws are… | 2003 |
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 |
|---|---|---|---|
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture… | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2025 | Class II | Z-1167-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1170-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1166-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1172-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1168-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1171-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1173-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Dec 17, 2025 | Class II | Z-1169-2026 | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K212912 (B-One Ortho, Corp., 2021) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K032224.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Fixone Biocomposite Interference Screws are indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193497: Fixone Biocomposite Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193497
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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