510(k) · Cleared

Cleared

Renovis Cannulated Screw System

K113084510(k) SpecialCleared Dec 9, 201152-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

Renovis Surgical Technologies, LLC · HWC Screw, Fixation, Bone

Cleared on Dec 9, 2011 as substantially equivalent to K092082 (Synergy Surgical Technologies, LLC, 2009) after a 52-day review. Its family tree reaches back 1 generation to 2009.

Decided: Dec 9, 2011
Review: 52 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K092082 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK092082 Synergy Cannulated Screw SystemSynergy Surgical Technologies, LLC · 2009
This deviceK113084 Renovis Cannulated Screw SystemRenovis Surgical Technologies, LLC · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K092082	Synergy Cannulated Screw System	Synergy Surgical Technologies, LLC	2009	—
0 (this device)	K113084	Renovis Cannulated Screw System	Renovis Surgical Technologies, LLC	2011	—

FIG. 1 — Lineage of K113084, 2009–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K092082	Synergy Cannulated Screw System Summary page 1 …21 CFR 888.3030 Class: 11 Product Code: HWC HTN C) Predicates: K092082 Synergy Cannulated Screw System D) Device Description: The Renovis Cannulated Screw System includes cannulated screws and washe…	Synergy Surgical Technologies, LLC	2009	—

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?

Its one ancestor has no recall.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Renovis Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsals; metatarsal and phalangeal osteotomnies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal Femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis;- and pelvis and acetabulurn fractures. T'his system is not indicated for use in the spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113084: Renovis Cannulated 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/K113084

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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