510(k) · Cleared

Cleared

Lactosorb Trauma Plating System

K971870510(k) TraditionalCleared Aug 19, 199790-day reviewClass II21 CFR 888.3030

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

Biomet, Inc. · HRS Plate, Fixation, Bone

Cleared on Aug 19, 1997 after a 90-day review. The FDA summary names no predicate by number. 96 later devices descend from it.

Decided: Aug 19, 1997
Review: 90 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

96 later devices descend from it, 11 citing it directly.

This deviceK971870 Lactosorb Trauma Plating SystemBiomet, Inc. · 1997
Descendant · cites it directly · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
Descendant · cites it directly · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
Descendant · cites it directly · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
Descendant · 2 generations on · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

1998high 16 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 96 · See all

K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · cites it directly86descendants
K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · cites it directly79descendants
K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · cites it directly73descendants
K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · 2 generations on65descendants
K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971870	Lactosorb Trauma Plating System	Biomet, Inc.	1997	—
+1	K982139	Biosorbfx 1.5/2.0 Bioabsorbable Fixation System	Bionx Implants, Inc.	1998	—
+1	K993061	Stryker Leibinger Resorbable Fixation System	Stryker Instruments	1999	—
+1	K011590	Resorb-X Resorbable Plating System	KLS-Martin L.P.	2002	—
+2	K060177	KLS Martin Rigid Fixation - Sterile	KLS Martin L.P.	2006	—
+3	K070169	KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile	KLS Martin L.P.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2000	1	0
2002	4	0
2004	2	0
2005	2	0
2006	2	0
2007	4	0
2008	3	0
2010	1	0
2011	2	0
2012	2	0
2013	2	0
2014	4	0
2015	3	0
2016	2	0
2018	1	0
2021	3	0
2022	4	0
2023	10	0
2024	13	0
2025	16	0
2026	12	0

FIG. 1 — Lineage of K971870, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (96)

See all 96

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

Number	Device	Applicant	Decided	Descendants
K982139	Biosorbfx 1.5/2.0 Bioabsorbable Fixation System	Bionx Implants, Inc.	1998	86
K993061	Stryker Leibinger Resorbable Fixation System	Stryker Instruments	1999	79
K011590	Resorb-X Resorbable Plating System	KLS-Martin L.P.	2002	73
K982721	Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System	Bionx Implants, Inc.	1999	6
K113109	Stryker Resorbable Fixation System	Stryker	2011	3
K051341	Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058…	Inion, Ltd.	2005	3
K992905	Codman Craniosorb Absorbable Fixation System	Codman & Shurtleff, Inc.	2000	3
K073006	Osteotrans -MX Bioabsorbable Bone Fixation System	Takiron Co., Ltd.	2008	2
K073115	Orthomesh	Synthes (Usa)	2008	1
K030425	Lorenz Resorbable Distraction System or Expander	Walter Lorenz Surgical, Inc.	2004	1

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, K982139 (Bionx Implants, Inc., 1998) has gone furthest, with 86 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications: 1. Comminuted fractures of the naso-ethmoidal infraorbital areas 2. Comminuted fractures of the frontal sinus wall 3. Pediatric midface or craniofacial trauma 4. Lefort (I,II,III) fractures 5. Orbital floor fractures 6. Fractures of the maxilla, Zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones 7. Trauma of the craniofacial…

Read the full statement (134 words)

A. General Indication: trauma procedures of the midface or craniofacial skeleton

Specific Indications:

1. Comminuted fractures of the naso-ethmoidal infraorbital areas

2. Comminuted fractures of the frontal sinus wall

3. Pediatric midface or craniofacial trauma

4. Lefort (I,II,III) fractures

5. Orbital floor fractures

6. Fractures of the maxilla, Zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones

7. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones

B. General Indication: reconstructive procedures of the midface or craniofacial skeleton

Specific Indications:

1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma etc.)

Lefort (I,IX,III) osteotomies

Tumor reconstruction in midface or craniofacial procedures

Bone graft procedures in the midface or craniofacial skeleton

Pediatric reconstructive procedures

Reconstructive procedures of the craniofacial skeleton including: frontal. parieta temporal, sphemoid, and occipital bones

7. Craniotom fixation

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/K971870 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971870: Lactosorb Trauma Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971870

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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