510(k) · Cleared

Cleared

Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw

K972919510(k) TraditionalCleared Mar 27, 1998232-day reviewClass II21 CFR 888.3040

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

Bionx Implants, Inc. · HWC Screw, Fixation, Bone

Cleared on Mar 27, 1998 as substantially equivalent to K921458 (Techmedica, Inc., 1992) and 3 other predicates after a 232-day review. Its family tree reaches back 1 generation to 1992. 87 later devices descend from it.

Decided: Mar 27, 1998
Review: 232 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K921458 (1992). 4 ancestors in all. 87 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK921458 TMP Microplating SystemTechmedica, Inc. · 1992
This deviceK972919 Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded…Bionx Implants, Inc. · 1998
Descendant · cites it directly · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
Descendant · 2 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
Descendant · 2 generations on · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
Descendant · 3 generations on · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
Descendant · 4 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007

Showing 5 of 87 descendants. See all descendants

Descendants cleared per year

1998high 15 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 87 · See all

K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · cites it directly86descendants
K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 2 generations on79descendants
K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · 2 generations on73descendants
K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · 3 generations on65descendants
K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 4 generations on61descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921458	TMP Microplating System	Techmedica, Inc.	1992	—
0 (this device)	K972919	Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw	Bionx Implants, Inc.	1998	—
+1	K982139	Biosorbfx 1.5/2.0 Bioabsorbable Fixation System	Bionx Implants, Inc.	1998	—
+2	K993061	Stryker Leibinger Resorbable Fixation System	Stryker Instruments	1999	—
+2	K011590	Resorb-X Resorbable Plating System	KLS-Martin L.P.	2002	—
+3	K060177	KLS Martin Rigid Fixation - Sterile	KLS Martin L.P.	2006	—
+4	K070169	KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile	KLS Martin L.P.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2002	3	0
2004	1	0
2005	1	0
2006	2	0
2007	2	0
2008	2	0
2010	1	0
2011	2	0
2012	2	0
2013	2	0
2014	4	0
2015	3	0
2016	2	0
2021	3	0
2022	4	0
2023	10	0
2024	13	0
2025	15	0
2026	12	0

FIG. 1 — Lineage of K972919, 1992–2026Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K921458	TMP Microplating System Summary page 1 …obrow Screw Common or Usual Name Bioabsorbable Threaded Fixation Rod Classification Name Bone Fixation Screw Predicate Devices (1) Techmedica, Inc. TMP Micoplate System (K921458) (2) W. Lorenz Surgical, Inc. LactoSorb® System (K955729) (3) Bionx Implants, Inc. BIOFIX® SR-PLLA Threaded Rod (K952871) (4) S…	Techmedica, Inc.	1992	—
*	K955729	Lactosorb Trauma Plating System Summary page 1 …ixation Rod Classification Name Bone Fixation Screw Predicate Devices (1) Techmedica, Inc. TMP Micoplate System (K921458) (2) W. Lorenz Surgical, Inc. LactoSorb® System (K955729) (3) Bionx Implants, Inc. BIOFIX® SR-PLLA Threaded Rod (K952871) (4) Synthes, Inc. PDLA Polypin (K961608) N\\\DC - 63547/1 - 0…	Poly-Medics,Inc.	1996	1
*	K952471	Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation Rod Our OCR of the scanned summary read K952871, FDA’s number for Ridges Plus (Octostop, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bionx Implants, Inc. BIOFIX® SR-PLLA Threaded Rod”.	Bioscience, Inc.	1995	—
*	K961608	Synthes (U.S.a.) Polypin Summary page 1 …stem (K921458) (2) W. Lorenz Surgical, Inc. LactoSorb® System (K955729) (3) Bionx Implants, Inc. BIOFIX® SR-PLLA Threaded Rod (K952871) (4) Synthes, Inc. PDLA Polypin (K961608) N\\\DC - 63547/1 - 0596938.01 Intended Use The BioSorb® SR-PDLA Endobrow Screw is intended for use in endoscop…	Synthes (Usa)	1997	—

Also cleared against K921458: 3 other devices →

What descends from it? (87)

See all 87

1 later device cites 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

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?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K982139 (Bionx Implants, Inc., 1998) has gone furthest, with 86 descendants of its own.
3 other devices also cite its predicate K921458.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The BioSorb® SR-PDLA Endobrow Screw is intended for use in Endoscopic Browplasty surgery. The Endobrow Screw will be specifically indicated for use to reattach the subdermis to the cranial bone in endoscopic browplasty procedures. The Endobrow Screw is used as a post to tie an absorbable suture to the subdermis. In conjunction with adequate surgical technique, the Endobrow Screw holds the subdermis securely in place to allow for reattachment to the cranial bone. Use absorbable sutures that provide wound support for at least thirty (30) days.

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/K972919 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972919: Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972919

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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