510(k) Report

510(k) · Cleared

Cleared

Sulzer Orthopedics Sysorb Interference Screws

K983592510(k) TraditionalCleared Jan 28, 1999107-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

Sulzer Orthopedics, Inc. · HWC Screw, Fixation, Bone

Cleared on Jan 28, 1999 after a 107-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.

Decided
Jan 28, 1999
Review
107 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2002: 1 descendant cleared2006: 1 descendant cleared2004: 1 descendant cleared2005: 2 descendants cleared2010: 2 descendants cleared2007: 2 descendants cleared2012: 3 descendants cleared2009: 1 descendant cleared2022: 1 descendant cleared2018: 2 descendants cleared2017: 2 descendants cleared1995200020052010201520202025
  1. This deviceK983592 Sulzer Orthopedics Sysorb Interference ScrewsSulzer Orthopedics, Inc. · 1999
  2. Descendant · cites it directly · 16 of its ownK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
  3. Descendant · 2 generations on · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
  4. Descendant · 3 generations on · 13 of its ownK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
  5. Descendant · 4 generations on · 5 of its ownK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010 · Recalled
  6. Descendant · 4 generations on · 3 of its ownK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1999: 12002: 12004: 12005: 22006: 12007: 22009: 12010: 22012: 32017: 22018: 22022: 1
1999high 3 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 19 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983592Sulzer Orthopedics Sysorb Interference ScrewsSulzer Orthopedics, Inc.1999—
+1K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020…Bionx Implants, Ltd.1999—
+2K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T…Linvatec Biomaterials, Inc.2004—
+3K052080Matryx Interference ScrewLinvatec Biomaterials, Inc.2005—
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503…Conmed Linvatec20102
+4K063588Matryx Interference Screw…Conmed Linvatec Biomaterials2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200410
200520
200610
200720
200910
201020
201230
201720
201820
202210
FIG. 1 — Lineage of K983592, 1999–2022Source: 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), 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. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Smith & Nephew (Acufex) Endo-Fix
Named without a submission number
—
*—Instrument Makar Biologically Quiet
Named without a submission number
—
*—Arthrex Bio-Interference
Named without a submission number
—
*—Linvatec Bioscrew
Named without a submission number
—

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd.199916
K021280Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd.20021

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, K993073 (Bionx Implants, Ltd., 1999) has gone furthest, with 16 descendants of its own.

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

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
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

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Sulzer Orthopedics Sysorb Interference Screws are intended for use in the following diagnostic indications:

1. Tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Sulzer Orthopedics, Inc.

45 FDA decisions under this applicant name. See the company

  • K022985Ascendent Acetabular SystemSulzer Orthopedics, Inc. · 20021 recall
  • K021578Natural-Knee II System Cocr Tibial BaseplateSulzer Orthopedics, Inc. · 2002
  • K020713MS-30 Lateral Femoral StemSulzer Orthopedics, Inc. · 20021 recall
  • K013935Allofit Acetabular System 32MM Alpha Durasul InsertsSulzer Orthopedics, Inc. · 2001
  • K013031Most Options SystemSulzer Orthopedics, Inc. · 20013 recalls

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K983592 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983592: Sulzer Orthopedics Sysorb Interference Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983592

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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