510(k) Report

510(k) · Cleared

Cleared

DJ Orthopedics Interference Screw

K010595510(k) TraditionalCleared May 8, 200169-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

Dj Orthopedics, LLC · HWC Screw, Fixation, Bone

Cleared on May 8, 2001 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
May 8, 2001
Review
69 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2004: 1 descendant cleared200020052010201520202025
  1. This deviceK010595 DJ Orthopedics Interference ScrewDj Orthopedics, LLC · 2001
  2. Descendant · cites it directly · 0 of its ownK033749 Titanium Cannulated Interference ScrewAdvanced Biomaterials · 2004
  3. Descendant · cites it directly · 0 of its ownK021030 Titanium Cannulated Interference ScrewFuture Medical Systems, Inc. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K033749Titanium Cannulated Interference ScrewAdvanced Biomaterials · 2004 · cites it directly0descendants
  • K021030Titanium Cannulated Interference ScrewFuture Medical Systems, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010595DJ Orthopedics Interference ScrewDj Orthopedics, LLC2001—
+1K033749Titanium Cannulated Interference ScrewAdvanced Biomaterials2004—
+1K021030Titanium Cannulated Interference ScrewFuture Medical Systems, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
FIG. 1 — Lineage of K010595, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K033749Titanium Cannulated Interference ScrewAdvanced Biomaterials20040
K021030Titanium Cannulated Interference ScrewFuture Medical Systems, Inc.20020

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, K033749 (Advanced Biomaterials, 2004) has gone furthest, with 0 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—

More from Dj Orthopedics, LLC

6 FDA decisions under this applicant name. See the company

  • K021740Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC · 2002
  • K011354High Tibial Osteotomy Plating SystemDj Orthopedics, LLC · 2001
  • K010594DJ Orthopedics Post ScrewDj Orthopedics, LLC · 2001
  • K002829DJ Orthopedics Femoral AnchorDj Orthopedics, LLC · 2001
  • K003960DJ Orthopedics Tibial AnchorDj Orthopedics, LLC · 2001

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/K010595 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010595: DJ Orthopedics 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/K010595

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026