510(k) Report

510(k) · Cleared

Cleared

Tenodesis screw system

K151701510(k) TraditionalCleared Jan 26, 2016216-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

Normed Medizin-Technik GmbH · HWC Screw, Fixation, Bone

Cleared on Jan 26, 2016 as substantially equivalent to K143165 (Zimmer, Inc., 2015) and 4 other predicates after a 216-day review. Its family tree reaches back 3 generations to 1995.

Decided
Jan 26, 2016
Review
216 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K943806 (1995). 24 ancestors in all, the oldest K931519 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestor2009: 2 other ancestors2006: 1 other ancestor2005: 1 other ancestor2008: 1 other ancestor2004: 1 other ancestor2003: 2 other ancestors2002: 1 other ancestor2001: 4 other ancestors1998: 2 other ancestors2000: 1 other ancestor1996: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestorK943806 · Harpoon Suture Anchors · Biomet, Inc. · 1995K012872 · Resorbable Screw Anchor · Arthrotek, Inc. · 2001K041274 · Resorbable Interference Screw · Arthrotek, Inc. · 2004 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 8 other ancestors3 generations back: 9 other ancestors K041274 · Resorbable Interference Screw · Arthrotek, Inc. · 2004 · recalledK012872 · Resorbable Screw Anchor · Arthrotek, Inc. · 2001K943806 · Harpoon Suture Anchors · Biomet, Inc. · 19950
  1. Root · 3 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
  2. 2 generations backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
  3. 1 generation backK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
  4. This deviceK151701 Tenodesis screw systemNormed Medizin-Technik GmbH · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K943806Harpoon Suture AnchorsBiomet, Inc.1995—
−2K012872Resorbable Screw AnchorArthrotek, Inc.2001—
−1K041274Resorbable Interference ScrewArthrotek, Inc.20045
0 (this device)K151701Tenodesis screw systemNormed Medizin-Technik GmbH2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199620
199820
200010
200140
200210
200320
200410
200510
200610
200810
200920
201510
FIG. 1 — Lineage of K151701, 1995–2016Source: 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
*K143165Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…
Summary page 5
…K151701 Page 2 of 3 4. Legally Marketed Predicate Device K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw K0612…
Zimmer, Inc.20152
*K061211NCB Plating System, Proximal Tibia Plates
Summary page 5
…4. Legally Marketed Predicate Device K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw K061211 – NCB Cannulated Screw K083150 - G-Force Tenodesis Screw K051726 - Arthrex Tenodesis Screw Family K041274 – Arthrex Resorbable…
Zimmer GmbH20064
*K083150G-Force Tenodesis Screw
Summary page 5
…vice K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw K061211 – NCB Cannulated Screw K083150 - G-Force Tenodesis Screw K051726 - Arthrex Tenodesis Screw Family K041274 – Arthrex Resorbable Interference Screw (Rattler Int…
Wrightmedicaltechnologyinc2009—
*K051726Arthrex Tenodesis Family
Summary page 5
…e Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw K061211 – NCB Cannulated Screw K083150 - G-Force Tenodesis Screw K051726 - Arthrex Tenodesis Screw Family K041274 – Arthrex Resorbable Interference Screw (Rattler Interference Screw) 5. Device Descr…
Arthrex, Inc.2005—
*K041274Resorbable Interference Screw
Summary page 5
…t Cannulated Bone Screw System, and Herbert Mini Bone Screw K061211 – NCB Cannulated Screw K083150 - G-Force Tenodesis Screw K051726 - Arthrex Tenodesis Screw Family K041274 – Arthrex Resorbable Interference Screw (Rattler Interference Screw) 5. Device Description The Tenodesis screw system is inte…
Arthrotek, Inc.20045

Also cleared against K143165: 4 other devices →

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?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
  • 5 of the 24 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K143165.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery.

The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers.

The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.

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

Also cleared against K143165

4 other devices cite the same predicate.

  • K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026
  • K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH · 2016
  • K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH · 20154 recalls
  • K151407RECON systemNormed Medizin-Technik GmbH · 2015

More from Normed Medizin-Technik GmbH

9 FDA decisions under this applicant name. See the company

  • K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH · 2016
  • K152256RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and ScrewsNormed Medizin-Technik GmbH · 2015
  • K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH · 20154 recalls
  • K152142RECON system - MPJ-PlatesNormed Medizin-Technik GmbH · 2015
  • K151407RECON systemNormed Medizin-Technik GmbH · 2015

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/K151701 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151701: Tenodesis screw system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151701

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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