510(k) · Cleared

Cleared

Phusis Absorbable Interference Screw

K970829510(k) TraditionalCleared Dec 22, 1998656-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

Tornier · HWC Screw, Fixation, Bone

Cleared on Dec 22, 1998 as substantially equivalent to K933719 (Linvatec Corp., 1994) and 1 other predicate after a 656-day review. Its family tree reaches back 1 generation to 1990. 17 later devices descend from it.

Decided: Dec 22, 1998
Review: 656 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K895711 (1990). 2 ancestors in all. 17 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK895711 Acufex Interference Screw, SterileAcufex Microsurgical, Inc. · 1990
This deviceK970829 Phusis Absorbable Interference ScrewTornier · 1998
Descendant · cites it directly · 16 of its ownK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
Descendant · 2 generations on · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
Descendant · 3 generations on · 13 of its ownK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
Descendant · 4 generations on · 5 of its ownK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010 · Recalled
Descendant · 4 generations on · 3 of its ownK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1999high 3 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 17 · See all

K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd. · 1999 · cites it directly16descendants
K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc. · 2004 · 2 generations on15descendants
K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005 · 3 generations on13descendants
K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec · 2010 · 4 generations on5descendants
K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials · 2007 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K895711	Acufex Interference Screw, Sterile	Acufex Microsurgical, Inc.	1990	—
0 (this device)	K970829	Phusis Absorbable Interference Screw	Tornier	1998	—
+1	K993073	Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020…	Bionx Implants, Ltd.	1999	—
+2	K032894	Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T…	Linvatec Biomaterials, Inc.	2004	—
+3	K052080	Matryx Interference Screw	Linvatec Biomaterials, Inc.	2005	—
+4	K101100	Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503…	Conmed Linvatec	2010	2
+4	K063588	Matryx Interference Screw…	Conmed Linvatec Biomaterials	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2004	1	0
2005	2	0
2007	2	0
2009	1	0
2010	2	0
2012	3	0
2017	2	0
2018	2	0
2022	1	0

FIG. 1 — Lineage of K970829, 1990–2022Source: 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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K933719	Bioscrew Absorbable Interference Screw Our OCR of the scanned summary read K933718, FDA’s number for Mugnier Jerik Sunglasses (Huntley Global Ent.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BioScrew Fixation System”.	Linvatec Corp.	1994	—
*	K895711	Acufex Interference Screw, Sterile Summary page 2 …rResponse.doc 5 6. Substantially Equivalent Device(s): 1. BioScrew Fixation System. Linvatec, Inc., K933718 2. Acufex Screw, Acufex Microsurgical, Inc., K895711 7. Indications for use: 1. Surgical repair of the anterior cruciate ligament. 2. ACL repair. 3. Arthroscopic ACL repair. 8. De…	Acufex Microsurgical, Inc.	1990	—

Also cleared against K933719: 5 other devices →

What descends from it? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993073	Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…	Bionx Implants, Ltd.	1999	16

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?

None of the 2 ancestors has a recall.
Of its descendants, K993073 (Bionx Implants, Ltd., 1999) has gone furthest, with 16 descendants of its own.
5 other devices also cite its predicate K933719.

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?

Interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

Open Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)

Arthroscopic ACL Reconstruction

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/K970829 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970829: Phusis Absorbable Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970829

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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