510(k) · Cleared
ClearedSingle Size Tendon Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medist International · HXA Prosthesis, Tendon, Passive
Cleared on Mar 29, 2000 after an 85-day review. The FDA summary names its predicate without a number. 41 later devices descend from it.
- Decided
- Mar 29, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- HXA
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 2 citing it directly.
- This deviceK000019 Single Size Tendon SpacerMedist International · 2000
- Descendant · cites it directly · 39 of its ownK053655 Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006
- Descendant · 2 generations on · 15 of its ownK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- Descendant · 3 generations on · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · 2 generations on · 13 of its ownK061473 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 12 of its ownK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K053655Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006 · cites it directly39descendants
- K080452Collagen Tendon WrapCollagen Matrix, Inc. · 2008 · 2 generations on15descendants
- K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · 3 generations on14descendants
- K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · 2 generations on13descendants
- K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000019 | Single Size Tendon Spacer | Medist International | 2000 | — |
| +1 | K053655 | Tendon Wrap Tendon Protector | Integra LifeSciences Corporation | 2006 | — |
| +2 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| +3 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +2 | K061473 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2006 | 1 |
| +2 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 9 | 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 Medical Technology Swanson Tendon Spacer Named without a submission number |
What descends from it? (41)
See all 412 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?
- Of its descendants, K053655 (Integra LifeSciences Corporation, 2006) has gone furthest, with 39 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 Single Size Tendon Spacers include: Scarred or adhering tendons due to trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is single use, temporary implantation for 2 to 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/K000019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000019: Single Size Tendon Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000019
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026