510(k) · Cleared
ClearedAvanta Orthopaedics Tendon Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanta Orthopaedics, Inc. · HXA Prosthesis, Tendon, Passive
Cleared on Mar 25, 1997 after a 144-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Mar 25, 1997
- Review
- 144 days
- Class
- Class II
- Product code
- HXA
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK964359 Avanta Orthopaedics Tendon SpacerAvanta Orthopaedics, Inc. · 1997
- Descendant · cites it directly · 10 of its ownK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- Descendant · 2 generations on · 9 of its ownK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- Descendant · 3 generations on · 5 of its ownK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
- Descendant · 4 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 5 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008 · cites it directly10descendants
- K083823Securian Tissue Reinforcement MatrixXylos Corporation · 2009 · 2 generations on9descendants
- K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011 · 3 generations on5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 4 generations on4descendants
- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964359 | Avanta Orthopaedics Tendon Spacer | Avanta Orthopaedics, Inc. | 1997 | — |
| +1 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
| +2 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| +3 | K111584 | Xylos Macro-Porous Surgical Mesh | Xylos Corporation | 2011 | — |
| +4 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +5 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 HXA? 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 HXA device
- #1 K243477 Universal Tendon Spacerscore 8.7 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | Wright Silastic Tendon Spacer Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072190 | Ortho-Wrap Bioresorbable Sheet | 2008 | 10 |
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?
- Of its descendants, K072190 (Mast Biosurgery, 2008) has gone furthest, with 10 descendants of its own.
How does its category compare?
All HXA devicesHXA Prosthesis, Tendon, Passive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HXA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HXA
Too few HXA 510(k)s in any year since 2007 to give a median.
Recalls per year · HXA
No recall names HXA since 2007.
Adverse event reports per year · HXA
1in 2021
MAUDE reports naming product code HXA, 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 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Surgical indications for the Avanta Orthopaedics Tendon Spacer include: Reconstruction of the flexor or extensor tendons of the fingers, thumb and wrist. Scared or adherent tendons following trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is a single-use, temporary implantation for 2-6 months.
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/K964359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964359: Avanta Orthopaedics Tendon Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964359
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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