510(k) Report

510(k) · Cleared

Cleared

Aap Cannulated Screws

K021233510(k) TraditionalCleared Dec 9, 2002235-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

Aap Implantate AG · HWC Screw, Fixation, Bone

Cleared on Dec 9, 2002 as substantially equivalent to K990776 (Aap Implantate AG, 1999) and 8 other predicates after a 235-day review. Its family tree reaches back 1 generation to 1981. 1 of the 191 devices in its family, counting itself, has a Class I recall. 181 later devices descend from it.

Decided
Dec 9, 2002
Review
235 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
9

Its longest line of descent runs back 1 generation to K810205 (1981). 9 ancestors in all. 181 later devices descend from it, 3 citing it directly. 1 of the 191 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 3 other ancestors1995: 1 other ancestor1992: 1 other ancestor1989: 2 other ancestors2011: 2 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2016: 4 descendants cleared2015: 11 descendants cleared2017: 11 descendants cleared2013: 3 descendants cleared2021: 10 descendants cleared, 1 with a Class I recall12024: 27 descendants cleared2014: 2 descendants cleared2012: 1 descendant cleared2020: 10 descendants cleared2019: 10 descendants cleared2022: 15 descendants cleared2023: 21 descendants cleared2026: 30 descendants cleared2025: 22 descendants clearedK810205 · Mecron Cancellous Cannulated Bone Screws · Serrano Intl. · 198119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors 1 generation forward: 3 descendants2 generations forward: 8 descendants3 generations forward: 15 descendants4 generations forward: 22 descendants5 generations forward: 27 descendants6 generations forward: 47 descendants, 1 with a Class I recall17 generations forward: 24 descendants8 generations forward: 17 descendants9 generations forward: 12 descendants10 generations forward: 4 descendants11 generations forward: 1 descendant12 generations forward: 1 descendant K810205 · Mecron Cancellous Cannulated Bone Screws · Serrano Intl. · 19810+5+10
  1. Root · 1 generation backK810205 Mecron Cancellous Cannulated Bone ScrewsSerrano Intl. · 1981
  2. This deviceK021233 Aap Cannulated ScrewsAap Implantate AG · 2002
  3. Descendant · cites it directly · 180 of its ownK080101 Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
  4. Descendant · 2 generations on · 145 of its ownK100359 Darco Headed Cannulated ScrewWrightmedicaltechnologyinc · 2010
  5. Descendant · 3 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  6. Descendant · 4 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
  7. Descendant · 5 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled

Showing 5 of 181 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12011: 22012: 12013: 32014: 22015: 112016: 42017: 112019: 102020: 102021: 102022: 152023: 212024: 272025: 222026: 30
2008high 30 (2026) · low 0 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 181 · See all
  • K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008 · cites it directly180descendants
  • K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc · 2010 · 2 generations on145descendants
  • K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 3 generations on79descendants
  • K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 4 generations on74descendants
  • K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 5 generations on69descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K810205Mecron Cancellous Cannulated Bone ScrewsSerrano Intl.1981—
0 (this device)K021233Aap Cannulated ScrewsAap Implantate AG2002—
+1K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG2008—
+2K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc2010—
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015—
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.2017—
+5K171651Excelsius GPSGlobus Medical, Inc.20171

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198920
199210
199510
199630
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201120
201210
201330
201420
2015110
201640
2017110
2019100
2020100
2021101
2022150
2023210
2024270
2025220
2026300
FIG. 1 — Lineage of K021233, 1981–2026Source: 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.

1 device in this family has a Class I recall. 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
*K990776Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
Summary page 1
…aap Small and Large Cannulated Screws are available in various length and various thread diameters. Predicate Devices for Substantial Equivalence: aap Cannulated Screws, K990776; aap's Bone Screws, K915316; OSTEOTECH Cannulated Screws, K950652; Synthes -Small and Large Cannulated Screw System, K962011 8 K9…
Aap Implantate AG1999—
*K915316Aap Bone Screw
Summary page 1
…ed Screws are available in various length and various thread diameters. Predicate Devices for Substantial Equivalence: aap Cannulated Screws, K990776; aap's Bone Screws, K915316; OSTEOTECH Cannulated Screws, K950652; Synthes -Small and Large Cannulated Screw System, K962011 8 K963192; HOWMEDICA ASNIS II Gu…
Aap International, Ltd.1992—
*K950652Osteotech Navicular and Cancellous Cannulated Screws
Summary page 1
…gth and various thread diameters. Predicate Devices for Substantial Equivalence: aap Cannulated Screws, K990776; aap's Bone Screws, K915316; OSTEOTECH Cannulated Screws, K950652; Synthes -Small and Large Cannulated Screw System, K962011 8 K963192; HOWMEDICA ASNIS II Guided Bone Screws, K895766; BIODYNAMIC…
Osteotech, Inc.1995—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…stantial Equivalence: aap Cannulated Screws, K990776; aap's Bone Screws, K915316; OSTEOTECH Cannulated Screws, K950652; Synthes -Small and Large Cannulated Screw System, K962011 8 K963192; HOWMEDICA ASNIS II Guided Bone Screws, K895766; BIODYNAMIC TECHNOLOGIES EZ-Fix TM Cannulated Screw System. K962706; De…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 1
…quivalence: aap Cannulated Screws, K990776; aap's Bone Screws, K915316; OSTEOTECH Cannulated Screws, K950652; Synthes -Small and Large Cannulated Screw System, K962011 8 K963192; HOWMEDICA ASNIS II Guided Bone Screws, K895766; BIODYNAMIC TECHNOLOGIES EZ-Fix TM Cannulated Screw System. K962706; DePuy Cannul…
Synthes (Usa)1996—
*K895766Asnis II Guided Bone Screw
Summary page 1
…s Bone Screws, K915316; OSTEOTECH Cannulated Screws, K950652; Synthes -Small and Large Cannulated Screw System, K962011 8 K963192; HOWMEDICA ASNIS II Guided Bone Screws, K895766; BIODYNAMIC TECHNOLOGIES EZ-Fix TM Cannulated Screw System. K962706; DePuy Cannulated Bone Screw, K893512; MECRON Cannulated Bone…
Howmedica Corp.1989—
*K962706EZ-Fix Cannulated Screw System
Summary page 1
…s -Small and Large Cannulated Screw System, K962011 8 K963192; HOWMEDICA ASNIS II Guided Bone Screws, K895766; BIODYNAMIC TECHNOLOGIES EZ-Fix TM Cannulated Screw System. K962706; DePuy Cannulated Bone Screw, K893512; MECRON Cannulated Bone Screws, K810205; ZIMMER MAGNA-Fx Et Mini Magna-Fx Cannulated Screw…
Biodynamic Technologies, Inc.1996—
*K893512Depuy Cannulated Bone Screw
Summary page 1
…stem, K962011 8 K963192; HOWMEDICA ASNIS II Guided Bone Screws, K895766; BIODYNAMIC TECHNOLOGIES EZ-Fix TM Cannulated Screw System. K962706; DePuy Cannulated Bone Screw, K893512; MECRON Cannulated Bone Screws, K810205; ZIMMER MAGNA-Fx Et Mini Magna-Fx Cannulated Screw Fixation System (Stainless Steel) Comp…
Depuy, Inc.1989—
*K810205Mecron Cancellous Cannulated Bone Screws
Summary page 1
…II Guided Bone Screws, K895766; BIODYNAMIC TECHNOLOGIES EZ-Fix TM Cannulated Screw System. K962706; DePuy Cannulated Bone Screw, K893512; MECRON Cannulated Bone Screws, K810205; ZIMMER MAGNA-Fx Et Mini Magna-Fx Cannulated Screw Fixation System (Stainless Steel) Comparision o f Technological Characteristic…
Serrano Intl.1981—
*—ZIMMER MAGNA-Fx Et Mini Magna-Fx Cannulated Screw Fixation System (Stainless Steel)
Named without a submission number
—

Also cleared against K990776: 6 other devices →

What descends from it? (181)

See all 181

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

NumberDeviceApplicantDecidedDescendants
K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG2008180
K111316Aap Cannulated ScrewsAap Implantate AG201139
K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • None of the 9 ancestors has a recall.
  • Of its descendants, K080101 (Aap Implantate AG, 2008) has gone furthest, with 180 descendants of its own.
  • 6 other devices also cite its predicate K990776.

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 aap Small and Large Cannulated Screw System is intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aap's washers may be used with the screws in certain applications. Minimally invasive fracture / joint reconstructions Additive osteosynthesis for complex joint fractures Multiple- fragment joint fractures Femoral neck and femoral head fractures Femoral supracondylar fractures Tibial plateau fractures Simple…

Read the full statement (175 words)

The aap Small and Large Cannulated Screw System is intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aap's washers may be used with the screws in certain applications.

Minimally invasive fracture / joint reconstructions

Additive osteosynthesis for complex joint fractures

Multiple- fragment joint fractures

Femoral neck and femoral head fractures

Femoral supracondylar fractures

Tibial plateau fractures

Simple metaphyseal fractures

Simple epiphyseal fractures

Fractures of the head of the humerus

Fractures of the head of the tibia

Cooper fractures of the tibia

Fractures of the radius

Fractures of the wrist, ankle, elbow and shoulder

Scaphoid fractures and other fractures of the hand

Metatarsal fractures and other fractures of the foot

Ligament fixation of the proximal humerus

Fractures of the acetabulum

Fractures of the dorsal pelvic ring

Condylar fractures

Peadiatric epiphyseal and metaphyseal fractures

Ligament avulsion injuries (Apohysis)

Fractures of small joint bones

Malleolar fractures

Navicular fractures

Fractures of the calcaneus and talus

Arthrodesis of the ankle joint

Avulsion fracture and metatarsl V

Fractures of the tarsal region

Indications for use as stated in the FDA summary.

Also cleared against K990776

6 other devices cite the same predicate.

  • K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG · 2016
  • K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
  • K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006
  • K030619Odi 7.0MM Cannulated Screw SystemOrthopedic Designs, Inc. · 2003
  • K011821Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
  • K993762I.CO.S ScrewNew Deal, S.A. · 2000

More from Aap Implantate AG

37 FDA decisions under this applicant name. See the company

  • K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG · 2026
  • K233008Cannulated Headless Bone ScrewsAap Implantate AG · 2024
  • K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG · 2023
  • K211582LOQTEQ Proximal Humerus Plate 3.5 SystemAap Implantate AG · 2021
  • K210043LOQTEQ Distal Lateral Femur Plate 4.5 SystemAap Implantate AG · 2021

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The HWC category page

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https://510kreport.com/device/K021233 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021233: Aap Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021233

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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