510(k) · Cleared

Cleared

Biorc Anchor

K990770510(k) TraditionalCleared Jul 30, 1999143-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

Linvatec Corp. · HWC Screw, Fixation, Bone

Cleared on Jul 30, 1999 as substantially equivalent to K963932 (Linvatec Corp., 1997) and 2 other predicates after a 143-day review. Its family tree reaches back 3 generations to 1993.

Decided: Jul 30, 1999
Review: 143 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K926384 (1993). 10 ancestors in all, the oldest K892126 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK926384 Statak & Mini-Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1993
2 generations backK963369 Bio-AnchorLinvatec Corp. · 1997
1 generation backK983186 Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998
This deviceK990770 Biorc AnchorLinvatec Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K926384	Statak & Mini-Statak Soft Tissue Attachment Device	Zimmer, Inc.	1993	—
−2	K963369	Bio-Anchor	Linvatec Corp.	1997	—
−1	K983186	Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor	Linvatec Corp.	1998	—
0 (this device)	K990770	Biorc Anchor	Linvatec Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1994	1	0
1995	1	0
1996	1	0
1997	2	0

FIG. 1 — Lineage of K990770, 1993–1999Source: 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? (3)

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
*	K963932	Preloaded Soft Tissue Anchor Summary page 4 …invatec Anchor shouider, knee, foot, ankle, Single-use length Corp. elbow, wrist, hand and bladder Threaded device 510(K)# neck suspension procedures. that attaches soft K963932 tissue 1o bone. PREDICATE \| Suretac Soft tissue to bone fixation. Polyglyconate Sterile Ethylene Oxide 8mm x 16mm Acufex Single-u…	Linvatec Corp.	1997	—
*	K911837	Suretac Polyglyconate Absorbable Fixation Device Summary page 4 …o bone. PREDICATE \| Suretac Soft tissue to bone fixation. Polyglyconate Sterile Ethylene Oxide 8mm x 16mm Acufex Single-use Cannulated tack 510(K)# with ribs to hold the K911837 device in the bone. PREDICATE \| Pre-loaded Bio- \| Soft tissue to bone fixation for Poly(L-lactic acid) \| Sterile Ethylene Oxide 3…	Acufex Microsurgical, Inc.	1991	—
*	K983186	Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor Summary page 4 …rile Ethylene Oxide 3.5mm x 10.5mm Linvatec Corp \| Anchor shoulder, knee, foot, ankle, Single-use Ribbed device with 510(K)# elbow, wrist, hand and bladder a loop at the K983186 neck suspension procedures. proximal end to hold suture which attaches the soft tissue. wavice,, & “ Pl é DEPAR…	Linvatec Corp.	1998	—

What descends from it?

No later submission names this one as a predicate yet.

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 6 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
1 of the 10 ancestors has a recall of any class.

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 BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs Foot and Ankle 1. Hallux Valgus repairs 2. Medial or lateral instability repairs/reconstructions 3. Achilles tendon…

Read the full statement (160 words)

The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:

Shoulder

Bankart lesion repair

SLAP lesion repairs

Acromio-clavicular separation repairs

Rotator cuff tear repairs

Capsular shift or capsulolabral reconstructions

Biceps tenodesis

Deltoid repairs

Foot and Ankle

1. Hallux Valgus repairs

2. Medial or lateral instability repairs/reconstructions

3. Achilles tendon repalrs/reconstructlons

4. Midfoot reconstructions

Elbow, Wrist and Hand

1. Scapholunate ligament reconstructions

2. Ulnar or radial collateral ligament reconstructions

3. Lateral and Medial Epicondylitis

4. Biceps tendon reattachment

Knee

1. Extracapsular repairs and reattachments of:

a. medial collateral ligament

b. lateral collateral ligament

c. posterior oblique ligament or joint capsule to tibia

d. joint capsule closure to anterior proximal tibia

2. Extracapsular reconstruction, iliotibial band tenodesis

3. Patellar realignment and tendon repalr(%;)

Bladder Neck Suspension

1. Soft tissue fixation of the pubic bone for the purpose of

bladder neck suspension for female urinary incontinence

due to urethral hypermobility.

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/K990770 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990770: Biorc Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990770

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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