510(k) Report

510(k) · Cleared

Cleared

Two-Step Implant System

K181898510(k) TraditionalCleared Oct 26, 2018102-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

Trilliant Surgical · HWC Screw, Fixation, Bone

Cleared on Oct 26, 2018 as substantially equivalent to K122959 (Trilliant Surgical, Ltd., 2012) and 3 other predicates after a 102-day review. Its family tree reaches back 5 generations to 2002.

Decided
Oct 26, 2018
Review
102 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K013888 (2002). 18 ancestors in all, the oldest K954330 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2011: 1 other ancestor2003: 1 other ancestor2008: 1 other ancestor2005: 1 other ancestor2002: 2 other ancestors1996: 2 other ancestors2010: 1 other ancestor1998: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestorK013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 2002K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K062863 · Osteomed Extended 2.0/2.4CANNULATED Screw System · Osteomed LP · 2006K111536 · Metasurg Digifuse Implant · Metasurg · 2011K122959 · Hammer Toe Implant · Trilliant Surgical, Ltd. · 2012 · recalled199520002005201020152020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 2 other ancestors4 generations back: 3 other ancestors K122959 · Hammer Toe Implant · Trilliant Surgical, Ltd. · 2012 · recalledK111536 · Metasurg Digifuse Implant · Metasurg · 2011K062863 · Osteomed Extended 2.0/2.4CANNULATED Screw System · Osteomed LP · 2006K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 2002−50
  1. Root · 5 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
  2. 4 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
  3. 3 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
  4. 2 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
  5. 1 generation backK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
  6. This deviceK181898 Two-Step Implant SystemTrilliant Surgical · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K013888Fixation (Steinmann) PinsMiltex, Inc.2002—
−4K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc.2003—
−3K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006—
−2K111536Metasurg Digifuse ImplantMetasurg2011—
−1K122959Hammer Toe ImplantTrilliant Surgical, Ltd.20121
0 (this device)K181898Two-Step Implant SystemTrilliant Surgical2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199620
199810
200110
200220
200310
200510
200810
201010
201110
201210
FIG. 1 — Lineage of K181898, 2002–2018Source: 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? (4)

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
*K122959Hammer Toe Implant
Summary page 4
…Smooth, smooth metallic bone fixation fastener, k-wire Device Panel Orthopedic Primary Predicate Device Hammer Toe Implant (Trilliant Surgical, K122959) Secondary Predicate Tiger Headless Cannulated Screws (Trilliant Surgical, K112737) Devices…
Trilliant Surgical, Ltd.20121
*K112737Tiger Headless Cannulated Screws
Summary page 4
…Panel Orthopedic Primary Predicate Device Hammer Toe Implant (Trilliant Surgical, K122959) Secondary Predicate Tiger Headless Cannulated Screws (Trilliant Surgical, K112737) Devices Trilliant Surgical K-Wires (Trilliant Surgical, K121008)…
Trilliant Surgical, Ltd.20114
*K121008Trilliant Surgical K-Wires
Summary page 4
…Predicate Tiger Headless Cannulated Screws (Trilliant Surgical, K112737) Devices Trilliant Surgical K-Wires (Trilliant Surgical, K121008) KMedic External Fixation Devices - (Teleflex Medical Group, K03033…
Trilliant Surgical, Ltd.20121
*K030336Kmedic External Fixation Devices
Summary page 4
…Surgical K-Wires (Trilliant Surgical, K121008) KMedic External Fixation Devices - (Teleflex Medical Group, K030336) II. DEVICE DESCRIPTION The Two-Step Implant System is used for fixation of the bones of the foot and hand. The…
Teleflex Medical Group2003—

Also cleared against K122959: 1 other device →

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 16 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
  • 5 of the 18 ancestors have a recall of any class.
  • 1 other device also cites its predicate K122959.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Two-Step Implant System is intended for fixation of osteotomies and reconstruction of the bones of the foot and hand during procedures to correct deformities of the toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

Indications for use as stated in the FDA summary.

Also cleared against K122959

1 other device cites the same predicate.

  • K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014

More from Trilliant Surgical

4 FDA decisions under this applicant name. See the company

  • K212378Arsenal Ankle Plating SystemTrilliant Surgical · 2022
  • K191009Arsenal Plating SystemTrilliant Surgical · 2019
  • K172405Sniper Staple System, Non-SterileTrilliant Surgical · 2017

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/K181898 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181898: Two-Step Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181898

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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