510(k) Report

510(k) · Cleared

Cleared

HA-2000 Hydroxylapatite

K852765510(k) TraditionalCleared Sep 23, 198587-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

Orthomatrix, Inc. · LYC Bone Grafting Material, Synthetic

Cleared on Sep 23, 1985 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 33 later devices descend from it.

Decided
Sep 23, 1985
Review
87 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
0

33 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 4 descendants cleared2003: 2 descendants cleared2010: 1 descendant cleared2005: 1 descendant cleared2012: 2 descendants cleared2014: 2 descendants cleared2006: 1 descendant cleared2018: 2 descendants cleared2016: 1 descendant cleared2019: 2 descendants cleared2007: 1 descendant cleared2009: 3 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2013: 1 descendant cleared2024: 4 descendants cleared2023: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK852765 HA-2000 HydroxylapatiteOrthomatrix, Inc. · 1985
  2. Descendant · cites it directly · 16 of its ownK073070 Dio Biotite-H Implant SystemDio Department Dsi, Inc. · 2008
  3. Descendant · cites it directly · 15 of its ownK030682 Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc. · 2003
  4. Descendant · 2 generations on · 10 of its ownK112532 ET II Bio-SA Fixture SystemHiossen, Inc. · 2012
  5. Descendant · 2 generations on · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
  6. Descendant · 3 generations on · 9 of its ownK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · Recalled

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2003: 22005: 12006: 12007: 12008: 42009: 32010: 12012: 22013: 12014: 22016: 12017: 12018: 22019: 22022: 12023: 12024: 42025: 12026: 2
2003high 4 (2008) · low 0 (2004)2026

Most influential descendants

Showing 5 of 33 · See all
  • K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc. · 2008 · cites it directly16descendants
  • K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc. · 2003 · cites it directly15descendants
  • K112532ET II Bio-SA Fixture SystemHiossen, Inc. · 2012 · 2 generations on10descendants
  • K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · 2 generations on10descendants
  • K151626ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852765HA-2000 HydroxylapatiteOrthomatrix, Inc.1985—
+1K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc.2008—
+1K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc.2003—
+2K112532ET II Bio-SA Fixture SystemHiossen, Inc.2012—
+2K033398Laryngeal Augmentation ImplantBioform, Inc.2003—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.20161

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200510
200610
200710
200840
200930
201010
201220
201310
201420
201610
201710
201820
201920
202210
202310
202440
202510
202620
FIG. 1 — Lineage of K852765, 1985–2026Source: 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), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc.200816
K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc.200315

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, K073070 (Dio Department Dsi, Inc., 2008) has gone furthest, with 16 descendants of its own.

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.

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—

More from Orthomatrix, Inc.

8 FDA decisions under this applicant name. See the company

  • K010738Cannulated Plus Screw SystemOrthomatrix, Inc. · 2001
  • K001254Orthomatrix, Inc. Cerclage SystemOrthomatrix, Inc. · 2000
  • K992856Magellan Humeral Intramedullary NailOrthomatrix, Inc. · 2000
  • K992850Magellan Tibial Intramedullary NailOrthomatrix, Inc. · 2000
  • K852766HA-1000 & HA-500 Hydroxylapatite Tooth Root SubstiOrthomatrix, Inc. · 1985

Recent decisions in LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K852765 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852765: HA-2000 Hydroxylapatite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852765

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026