510(k) · Cleared
ClearedJax-TCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jun 10, 2004 after a 211-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Jun 10, 2004
- Review
- 211 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK033552 Jax-TCPSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK051722 Tricos TBaxter Healthcare Corp · 2005
- Descendant · 2 generations on · 2 of its ownK073571 Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation · 2008
- Descendant · 2 generations on · 0 of its ownK081717 Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp · 2008
- Descendant · 2 generations on · 0 of its ownK081721 Tricos a Resorbable SubstituteBaxter Healthcare Corp · 2008
Most influential descendants
Showing 4 of 4 · See all- K051722Tricos TBaxter Healthcare Corp · 2005 · cites it directly3descendants
- K073571Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation · 2008 · 2 generations on2descendants
- K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp · 2008 · 2 generations on0descendants
- K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033552 | Jax-TCP | Smith & Nephew, Inc. | 2004 | — |
| +1 | K051722 | Tricos T | Baxter Healthcare Corp | 2005 | — |
| +2 | K073571 | Tricos T Resorbable Bone Substitute | Baxter Healthcare Corporation | 2008 | — |
| +2 | K081717 | Tricos a Resorbable Bone Substitute | Baxter Healthcare Corp | 2008 | — |
| +2 | K081721 | Tricos a Resorbable Substitute | Baxter Healthcare Corp | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 3 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051722 | Tricos T | 2005 | 3 |
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, K051722 (Baxter Healthcare Corp, 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
The Jax-tcp granules may be used alone or can be mixed with the gel to create a cohesive mass that can be applied to the defect site. The get is contradicted for use without the use of the granules. When used together, the granules and gel should be combined in a 1:1 ratio. JAX-tcp is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. JAX-tcp is indicated to be gently packed into bony voids or gaps of the…
Read the full statement (129 words)
The Jax-tcp granules may be used alone or can be mixed with the gel to create a cohesive mass that can be applied to the defect site. The get is contradicted for use without the use of the granules. When used together, the granules and gel should be combined in a 1:1 ratio.
JAX-tcp is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. JAX-tcp is indicated to be gently packed into bony voids or gaps of the skeletal system, (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. JAX-tcp provides a filter that is resorbed and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033552: Jax-TCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033552
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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