510(k) Report

510(k) · Cleared

Cleared

Endo Absorbable Interference Screw

K980457510(k) TraditionalCleared Sep 8, 1998215-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

Endo Surgical Concepts, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 8, 1998 as substantially equivalent to K935836 (Endo Surgical Concepts, Inc., 1994) and 3 other predicates after a 215-day review. Its family tree reaches back 1 generation to 1994.

Decided
Sep 8, 1998
Review
215 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K935836 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestors1994: 1 other ancestorK935836 · Bone or Interference Screw · Endo Surgical Concepts, Inc. · 1994199019921994199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors K935836 · Bone or Interference Screw · Endo Surgical Concepts, Inc. · 19940
  1. Root · 1 generation backK935836 Bone or Interference ScrewEndo Surgical Concepts, Inc. · 1994
  2. This deviceK980457 Endo Absorbable Interference ScrewEndo Surgical Concepts, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935836Bone or Interference ScrewEndo Surgical Concepts, Inc.1994—
0 (this device)K980457Endo Absorbable Interference ScrewEndo Surgical Concepts, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
FIG. 1 — Lineage of K980457, 1994–1998Source: 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? (5)

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
*K935836Bone or Interference Screw
Summary page 1
…ws Common Name: Bone or Interference Screw Classification Name:Bone or Interference Screw Equivalent Device: ENDO Surgical Concepts, Greenwich, CT, Interference Screws K935836 Linvatec, Clearwater, FL. Concept Absorbable Interference Screws or Bioscrew K933719, K952831 Acufex, Mansfield, MA Interferenc…
Endo Surgical Concepts, Inc.1994—
*K933719Bioscrew Absorbable Interference Screw
Summary page 1
…rew Equivalent Device: ENDO Surgical Concepts, Greenwich, CT, Interference Screws K935836 Linvatec, Clearwater, FL. Concept Absorbable Interference Screws or Bioscrew K933719, K952831 Acufex, Mansfield, MA Interference Screws and Ligament Button and Bioabsorbable Interference Screw K943548 Richards, Me…
Linvatec Corp.1994—
*K952831Bioscrew Absorbable Interference Screw
Summary page 1
…valent Device: ENDO Surgical Concepts, Greenwich, CT, Interference Screws K935836 Linvatec, Clearwater, FL. Concept Absorbable Interference Screws or Bioscrew K933719, K952831 Acufex, Mansfield, MA Interference Screws and Ligament Button and Bioabsorbable Interference Screw K943548 Richards, Memphis, TN…
Linvatec Corp.1995—
*K943548Bioabsorbable Interference Screw
Summary page 1
…. Concept Absorbable Interference Screws or Bioscrew K933719, K952831 Acufex, Mansfield, MA Interference Screws and Ligament Button and Bioabsorbable Interference Screw K943548 Richards, Memphis, TN, Hewson Ligament Button Intended Use: Bone to bone fixation, fixation of bone patella bone and semitendono…
Acufex Microsurgical, Inc.1995—
*—Richards Hewson Ligament Button
Named without a submission number
—

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?

  • None of the 4 ancestors has a recall.

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 ENDO Absorbable Interference Screw is indicated for use in graft fixation in the repair and reconstruction of the cruciate ligaments of the knee, during open and arthroscopic surgery.

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

More from Endo Surgical Concepts, Inc.

2 FDA decisions under this applicant name. See the company

  • K935836Bone or Interference ScrewEndo Surgical Concepts, Inc. · 1994

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https://510kreport.com/device/K980457 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980457: Endo Absorbable Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980457

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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