Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254280

F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho

Q: How to monitor F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho and peer orthopedic records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho: 510(k) cleared for Steps Ortho. Its amount of 265 is above the median of 138 (85th percentile). Dated 45 days ago, it serves as a historical benchmark. Score 61/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 265 · 85th percentile of 414 FDAPulse records · 1.9x the median

Free preview: all 14 published fields of this record are shown below. Locked: 5 related FR FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K254280
Device	F.A.S.T Screw
Applicant	Steps Ortho
Specialty / panel	Orthopedic
Product code	HWC
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2025-12-30
Decision date	2026-09-21
Review time (days)	265
Third-party review	No
Applicant location	Bron, FR
amount percentile	85th of 414 (median 138, 1.9x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-21
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho and 6 FR peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

FR FDAPulse records like this one: 6
F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho's amount: 85th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every FR peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

61 / 100 Predicate Speed & CAPA Advisory Opportunity Score

A long 265-day review suggests additional-information requests: a firm likely to value regulatory help next time.
Posted 45 days ago.

What is the FDAPulse record for F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho?

F.A.S.T Screw (K254280) by Steps Ortho was cleared on 2026-09-21 after 265 days of review.

How does F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho compare to other FDAPulse records?

Its amount of 265 sits in the upper half (85th percentile) of 414 records; the median is 138. It is 45 days old, still within a typical 45-day follow-up window.

F.A.S.T Screw (K254280) vs. top 3 peers

Organization	Location	Record date
F.A.S.T Screw (K254280)	FR	2026-09-21
TruVision Single-Use 1.9mm Arthroscopy System (K260156)	UT	2026-10-09
Kentrospine Viktr-MIS® Pedicle screw system (K252139)	IN	2026-09-27
The VEGA Cervical Screw System (K254260)	KR	2026-09-17

How to monitor F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho and peer orthopedic records

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