510(k) Report

510(k) · Cleared

Cleared

Tricos T Resorbable Bone Substitute

K073571510(k) AbbreviatedCleared Apr 8, 2008110-day reviewClass II21 CFR 872.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Baxter Healthcare Corporation · LYC Bone Grafting Material, Synthetic

Cleared on Apr 8, 2008 as substantially equivalent to K051722 (Baxter Healthcare Corp, 2005) and 1 other predicate after a 110-day review. Its family tree reaches back 4 generations to 1999. 2 later devices descend from it.

Decided
Apr 8, 2008
Review
110 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K990131 (1999). 19 ancestors in all, the oldest K871773 (1987). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 4 other ancestors2001: 1 other ancestor2000: 2 other ancestors1998: 2 other ancestors1995: 2 other ancestors1992: 1 other ancestor1987: 1 other ancestor2003: 2 other ancestors2008: 2 descendants clearedK990131 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute · Interpore Cross Intl. · 1999K020986 · Mastergraft Resorbable Ceramic · Medtronic Sofamor Danek, Inc. · 2002K032268 · MBCP · Biomatlante · 2003K051722 · Tricos T · Baxter Healthcare Corp · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 11 other ancestors3 generations back: 3 other ancestors 1 generation forward: 2 descendants K051722 · Tricos T · Baxter Healthcare Corp · 2005K032268 · MBCP · Biomatlante · 2003K020986 · Mastergraft Resorbable Ceramic · Medtronic Sofamor Danek, Inc. · 2002K990131 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute · Interpore Cross Intl. · 19990
  1. Root · 4 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
  2. 3 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
  3. 2 generations backK032268 MBCPBiomatlante · 2003
  4. 1 generation backK051722 Tricos TBaxter Healthcare Corp · 2005
  5. This deviceK073571 Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation · 2008
  6. Descendant · cites it directly · 0 of its ownK081717 Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp · 2008
  7. Descendant · cites it directly · 0 of its ownK081721 Tricos a Resorbable SubstituteBaxter Healthcare Corp · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp · 2008 · cites it directly0descendants
  • K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K990131Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl.1999—
−3K020986Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc.2002—
−2K032268MBCPBiomatlante2003—
−1K051722Tricos TBaxter Healthcare Corp2005—
0 (this device)K073571Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation2008—
+1K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp2008—
+1K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199210
199520
199820
200020
200110
200320
200440

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
FIG. 1 — Lineage of K073571, 1999–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LYC? 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 LYC device

  1. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K051722Tricos T
Summary page 2
…nt to Baxter's current legally marketed TricOs T Resorbable Bone Substitute cleared by 510(k) K051722 with regard to technological characteristics, performance, and…
Baxter Healthcare Corp2005—
*K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen
Summary page 1
…able Bone Substitute (KO51722) Geistlich BIO-OSS®, BIO-OSS® Blocks and BIO- OSS® Collagen (K033815) STATEMENT OF INTENDED USE: TricOs T Resorbable Bone Substitute is indicated for…
Geistlich-Pharma2004—

Also cleared against K051722: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp20080
K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp20080

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 9 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
  • 2 of the 19 ancestors have a recall of any class.
  • Of its descendants, K081717 (Baxter Healthcare Corp, 2008) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K051722.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

What is it indicated for?

TricOs T Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs T…

Read the full statement (110 words)

TricOs T Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs T Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs T Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K073571: Tricos T Resorbable Bone Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073571

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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