510(k) Report

510(k) · Cleared

Cleared

Orthopediatrics Bone Screws

K082949510(k) TraditionalCleared Nov 25, 200854-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

OrthoPediatrics Corp. · HWC Screw, Fixation, Bone

Cleared on Nov 25, 2008 as substantially equivalent to K002271 (Synthes (Usa), 2000) and 9 other predicates after a 54-day review. Its family tree reaches back 2 generations to 1986. 11 later devices descend from it.

Decided
Nov 25, 2008
Review
54 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
10

Its longest line of descent runs back 2 generations to K862157 (1986). 13 ancestors in all. 11 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestor1996: 4 other ancestors1990: 1 other ancestor2011: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared2019: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants clearedK862157 · Omc Orthomet Cannulated Screw · Orthomet, Inc. · 1986K043410 · Epiphysis Screw · I.T.S. Implantat-Technologie-Systeme GmbH · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 2 descendants K043410 · Epiphysis Screw · I.T.S. Implantat-Technologie-Systeme GmbH · 2005K862157 · Omc Orthomet Cannulated Screw · Orthomet, Inc. · 19860
  1. Root · 2 generations backK862157 Omc Orthomet Cannulated ScrewOrthomet, Inc. · 1986
  2. 1 generation backK043410 Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH · 2005
  3. This deviceK082949 Orthopediatrics Bone ScrewsOrthoPediatrics Corp. · 2008
  4. Descendant · cites it directly · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
  6. Descendant · cites it directly · 2 of its ownK110959 Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
  7. Descendant · 2 generations on · 1 of its ownK162307 OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016
  8. Descendant · cites it directly · 1 of its ownK140431 Pediloc Fragment SystemOrthoPediatrics Corp. · 2014

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 22014: 12016: 12017: 12019: 12020: 22025: 22026: 1
2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 11 · See all
  • K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · cites it directly7descendants
  • K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on2descendants
  • K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · cites it directly2descendants
  • K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016 · 2 generations on1descendant
  • K140431Pediloc Fragment SystemOrthoPediatrics Corp. · 2014 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K862157Omc Orthomet Cannulated ScrewOrthomet, Inc.1986—
−1K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH2005—
0 (this device)K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.2008—
+1K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.20111
+2K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.20191
+1K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.20113
+2K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.2016—
+1K140431Pediloc Fragment SystemOrthoPediatrics Corp.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199640
199910
200020
200110
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201410
201610
201710
201910
202020
202520
202610
FIG. 1 — Lineage of K082949, 1986–2026Source: 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? (10)

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
*K0022712.4MM Cortex Screw, Self-Tapping
Summary page 1
…Screw: Class II per 21 CFR §888.3040 DEVICE PRODUCT CODE(S): HWC SUBSTANTIALLY EQUIVALENT DEVICES: Synthes (K002271), Synthes (USA) Synthes (K012945), Synthes (USA) Synthes (K021932), Synthes (USA)…
Synthes (Usa)2000—
*K012945Synthes 2.4 MM Cannulated Screw
Summary page 1
…CFR §888.3040 DEVICE PRODUCT CODE(S): HWC SUBSTANTIALLY EQUIVALENT DEVICES: Synthes (K002271), Synthes (USA) Synthes (K012945), Synthes (USA) Synthes (K021932), Synthes (USA) Synthes (K043185), Synthes (USA)…
Synthes (Usa)20011
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 1
…C SUBSTANTIALLY EQUIVALENT DEVICES: Synthes (K002271), Synthes (USA) Synthes (K012945), Synthes (USA) Synthes (K021932), Synthes (USA) Synthes (K043185), Synthes (USA) Synthes (K962011), Synthes (USA)…
Synthes (Usa)20027
*K043185Synthes 3.5MM Cortex Screws
Summary page 1
…Synthes (K002271), Synthes (USA) Synthes (K012945), Synthes (USA) Synthes (K021932), Synthes (USA) Synthes (K043185), Synthes (USA) Synthes (K962011), Synthes (USA) Synthes (K962823), Synthes (USA)…
Synthes (Usa)2005—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…Synthes (K012945), Synthes (USA) Synthes (K021932), Synthes (USA) Synthes (K043185), Synthes (USA) Synthes (K962011), Synthes (USA) Synthes (K962823), Synthes (USA) Synthes (K963172), Synthes (USA)…
Synthes (Usa)1996—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 1
…Synthes (K021932), Synthes (USA) Synthes (K043185), Synthes (USA) Synthes (K962011), Synthes (USA) Synthes (K962823), Synthes (USA) Synthes (K963172), Synthes (USA) Synthes (K963192), Synthes (USA)…
Synthes (Usa)1996—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 1
…Synthes (K043185), Synthes (USA) Synthes (K962011), Synthes (USA) Synthes (K962823), Synthes (USA) Synthes (K963172), Synthes (USA) Synthes (K963192), Synthes (USA) Biomet (K984209), Biomet, Inc.…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 1
…Synthes (K962011), Synthes (USA) Synthes (K962823), Synthes (USA) Synthes (K963172), Synthes (USA) Synthes (K963192), Synthes (USA) Biomet (K984209), Biomet, Inc. I.T.S. (K043410), I.T.S. DEVICE DESCRIPTI…
Synthes (Usa)1996—
*K984209Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw…
Summary page 1
…Synthes (K962823), Synthes (USA) Synthes (K963172), Synthes (USA) Synthes (K963192), Synthes (USA) Biomet (K984209), Biomet, Inc. I.T.S. (K043410), I.T.S. DEVICE DESCRIPTION: Cannulated screws are machined, metallic screws…
Biomet, Inc.19994
*K043410Epiphysis Screw
Summary page 1
…Synthes (K963172), Synthes (USA) Synthes (K963192), Synthes (USA) Biomet (K984209), Biomet, Inc. I.T.S. (K043410), I.T.S. DEVICE DESCRIPTION: Cannulated screws are machined, metallic screws with a cannulation that are self drilling and sel…
I.T.S. Implantat-Technologie-Systeme GmbH2005—

Also cleared against K002271: 1 other device →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.20117
K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.20112
K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141

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 22 years and passes through 3 companies; a new generation was cleared every 18.5 years on median.
  • 4 of the 13 ancestors have a recall of any class.
  • Of its descendants, K111086 (OrthoPediatrics Corp., 2011) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K002271.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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?

Cortical Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula. Large Cannulated Screws (4.5mm diameter and larger) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5mm and larger are intended for large bones and large bone fragments such as femoral neck fractures; slipped capital femoral…

Read the full statement (117 words)

Cortical Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.

Large Cannulated Screws (4.5mm diameter and larger) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5mm and larger are intended for large bones and large bone fragments such as femoral neck fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.

Small Cannulated Screws (4.0mm diameter and smaller) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

Indications for use as stated in the FDA summary.

Also cleared against K002271

1 other device cites the same predicate.

  • K011946The Spin Snap-Off ScrewNew Deal, S.A. · 2001

More from OrthoPediatrics Corp.

41 FDA decisions under this applicant name. See the company

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  • K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp. · 2026
  • K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp. · 2025
  • K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp. · 2025
  • K243963Pediatric Plating Platform HipOrthoPediatrics Corp. · 2025

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
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https://510kreport.com/device/K082949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082949: Orthopediatrics Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082949

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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