510(k) Report

510(k) · Cleared

Cleared

Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple

K121277510(k) TraditionalCleared Nov 7, 2012194-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

Z-Medical GmbH & Co. KG · HWC Screw, Fixation, Bone

Cleared on Nov 7, 2012 as substantially equivalent to K050819 (Wrightmedicaltechnologyinc, 2005) and 5 other predicates after a 194-day review. Its family tree reaches back 3 generations to 1996. 24 later devices descend from it.

Decided
Nov 7, 2012
Review
194 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K961522 (1996). 11 ancestors in all, the oldest K894929 (1989). 24 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2005: 4 other ancestors1996: 1 other ancestor2007: 1 other ancestor1989: 1 other ancestor2018: 2 descendants cleared2013: 2 descendants cleared2022: 1 descendant cleared2023: 3 descendants cleared2015: 2 descendants cleared2017: 2 descendants cleared2024: 5 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedK961522 · Kirschner Wire (K-Wire) and Steinmann Pin · Synvasive Technology, Inc. · 1996K030665 · Bone Wire · Stork Instrumente GmbH · 2003K100736 · Kirschner and Guide Wires · Smt Schilling Metalltechnik GmbH · 20101990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant K100736 · Kirschner and Guide Wires · Smt Schilling Metalltechnik GmbH · 2010K030665 · Bone Wire · Stork Instrumente GmbH · 2003K961522 · Kirschner Wire (K-Wire) and Steinmann Pin · Synvasive Technology, Inc. · 19960+5
  1. Root · 3 generations backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
  2. 2 generations backK030665 Bone WireStork Instrumente GmbH · 2003
  3. 1 generation backK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
  4. This deviceK121277 Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire…Z-Medical GmbH & Co. KG · 2012
  5. Descendant · cites it directly · 15 of its ownK131061 Restore Bunion Correction SystemNextremity Solutions · 2013
  6. Descendant · 2 generations on · 8 of its ownK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
  7. Descendant · cites it directly · 6 of its ownK222645 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022
  8. Descendant · 3 generations on · 5 of its ownK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
  9. Descendant · cites it directly · 4 of its ownK232387 Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts · 2023

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2013: 22015: 22017: 22018: 22019: 12020: 12021: 22022: 12023: 32024: 52025: 12026: 2
2013high 5 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 24 · See all
  • K131061Restore Bunion Correction SystemNextremity Solutions · 2013 · cites it directly15descendants
  • K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017 · 2 generations on8descendants
  • K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022 · cites it directly6descendants
  • K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019 · 3 generations on5descendants
  • K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts · 2023 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K961522Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc.1996—
−2K030665Bone WireStork Instrumente GmbH2003—
−1K100736Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH2010—
0 (this device)K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG2012—
+1K131061Restore Bunion Correction SystemNextremity Solutions2013—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC2017—
+1K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts2022—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics2019—
+1K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199610
200540
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201520
201720
201820
201910
202010
202120
202210
202330
202450
202510
202620
FIG. 1 — Lineage of K121277, 1996–2026Source: 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), 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? (6)

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
*K050819Charlotte Snap-Off Screw
Summary page 3
…ice Predicate Device 510(k) Number 51 0(k) Holder 7-Snap Off Screw CHARLOTTE Snap-Oft Screw K050819 Wright Medical Technology 7-Double Thread Foot and Hand Motion System K091 118 Newcl…
Wrightmedicaltechnologyinc2005—
*K091118Foot and Hand Motion System
Summary page 3
…CHARLOTTE Snap-Oft Screw K050819 Wright Medical Technology 7-Double Thread Foot and Hand Motion System K091 118 Newclip Technics Compression Screw Synthes 3.0 rum Headless Compression K050636 Synthes (USA)…
Newclip Technics2009—
*K050636Synthes 3.0MM Headless Compression Screws
Summary page 3
…read Foot and Hand Motion System K091 118 Newclip Technics Compression Screw Synthes 3.0 rum Headless Compression K050636 Synthes (USA) Screw 7-Guide wire Orthopaedic Fixation Pins and Wir…
Synthes (Usa)20051
*K100736Kirschner and Guide Wires
Summary page 3
…m Headless Compression K050636 Synthes (USA) Screw 7-Guide wire Orthopaedic Fixation Pins and Wires / K100736 SMT Schilling Metalltechnik GmbH Kirschner / Guide Wires 7-Staple…
Smt Schilling Metalltechnik GmbH2010—
*K043059Compression Staple and Simple Staple
Summary page 3
…SMT Schilling Metalltechnik GmbH Kirschner / Guide Wires 7-Staple Compression Staple and Simple Staple K043059 Wright Medical Technology MLI Modular Staples K962705 Medic…
Wrightmedicaltechnologyinc2005—
*K962705Mli Modular Staple
Summary page 3
…Compression Staple and Simple Staple K043059 Wright Medical Technology MLI Modular Staples K962705 Medicine Lodge Inc. 4. Description of the Device 4.1. Z-Snap Off Screw Main application of the Snap Off Screw is t…
Medicinelodge, Inc.1996—

Also cleared against K050819: 6 other devices →

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K131061Restore Bunion Correction SystemNextremity Solutions201315
K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226
K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234
K151160Arcus Staple SystemNextremity Solutions, Inc.20151
K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180
K172205ExoToe StapleExotoe, LLC20180
K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130

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 16 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K131061 (Nextremity Solutions, 2013) has gone furthest, with 15 descendants of its own.
  • 6 other devices also cite its predicate K050819.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: * Fixation of small bone fragments * Well osteotomy * Mono-cortical fixation * Osteotomies and fractures fixation in the foot and hand The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included: * Fixation of bone fragments or small bone fractures * Fracture…

Read the full statement (155 words)

The Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

* Fixation of small bone fragments

* Well osteotomy

* Mono-cortical fixation

* Osteotomies and fractures fixation in the foot and hand

The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included:

* Fixation of bone fragments or small bone fractures

* Fracture management in the foot and hand

* Arthrodesis in hand, foot or ankle surgery

* Mono or Bi-cortical osteotomies in the foot and hand

The Z-Medical's guide wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.

The Z-Medical Staples are indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples included:

* Fixation of bone fragments or small bones fractures

* Fracture management in the foot and hand

Indications for use as stated in the FDA summary.

Also cleared against K050819

6 other devices cite the same predicate.

  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  • K133713Charlotte (TM) Snap-Off ScrewWrightmedicaltechnologyinc · 2014
  • K130627Swing-Off ScrewAdvanced Interventional Technology, LLC · 2013
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 20132 recalls
  • K120390Solafix Twist Screw Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 20121 recall

More from Z-Medical GmbH & Co. KG

2 FDA decisions under this applicant name. See the company

  • K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG · 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/K121277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121277

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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