510(k) · Cleared

Cleared

CREED™ Cannulated Screws

K200291510(k) TraditionalCleared Dec 16, 2020315-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

Glw Medical, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 16, 2020 as substantially equivalent to K160304 (Phalanx Innovations, 2016) and 3 other predicates after a 315-day review. Its family tree reaches back 7 generations to 1979. 2 later devices descend from it.

Decided: Dec 16, 2020
Review: 315 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 4

Its longest line of descent runs back 7 generations to K792022 (1979). 40 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 7 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
6 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
5 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
4 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
3 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
2 generations backK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
1 generation backK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
This deviceK200291 CREED™ Cannulated ScrewsGlw Medical, Inc. · 2020
Descendant · cites it directly · 0 of its ownK223847 CREED™ Cannulated ScrewsGlw, Inc. · 2023
Descendant · cites it directly · 0 of its ownK221489 Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022

Most influential descendants

Showing 2 of 2 · See all

K223847CREED™ Cannulated ScrewsGlw, Inc. · 2023 · cites it directly0descendants
K221489Artemis Proximal Femoral Nail SystemGlw, Inc. · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K792022	Herbert Bone Screw	Zimmer, Inc.	1979	6
−6	K974876	Bionx Distal Radius Screw	Bionx Implants, Inc.	1998	—
−5	K992947	Cannulated Smartscrew Models 224540C, 224570C	Bionx Implants, Ltd.	1999	—
−4	K012001	Smartscrew	Bionx Implants, Ltd.	2001	—
−3	K030900	Inion Otps Biodegradable Fixaton System	Inion, Ltd.	2003	—
−2	K123672	Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)	Inion OY	2013	—
−1	K160304	OsteoBullet Compression Screw	Phalanx Innovations	2016	—
0 (this device)	K200291	CREED™ Cannulated Screws	Glw Medical, Inc.	2020	—
+1	K223847	CREED™ Cannulated Screws	Glw, Inc.	2023	—
+1	K221489	Artemis Proximal Femoral Nail System	Glw, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	2	0
1995	2	0
1996	6	0
1997	2	0
1998	1	0
1999	1	0
2000	2	0
2001	4	0
2002	3	0
2003	1	0
2004	2	0
2005	2	0
2006	1	0
2007	1	0
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0
2023	1	0

FIG. 1 — Lineage of K200291, 1979–2023Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K160304	OsteoBullet Compression Screw Summary page 4 …gulation 21 CFR 888.3040 Number Product Code HWC Name of Primary 510(k) # Manufacturer Predicate Device OsteoBullet Compression K160304 Phalanx Innovations Screw Name of Additional Predicate Devices DARCO Headless K080850 Wright Medica…	Phalanx Innovations	2016	—
*	K080850	Darco Headless Compression Screw Summary page 4 …Manufacturer Predicate Device OsteoBullet Compression K160304 Phalanx Innovations Screw Name of Additional Predicate Devices DARCO Headless K080850 Wright Medical Technology Inc. Compression Screw Biomet BioDrive Cannulated K082874 Biomet Screw System Inion…	Wrightmedicaltechnologyinc	2008	—
*	K082874	Biodrive Cannulated Screw System Summary page 4 …ns Screw Name of Additional Predicate Devices DARCO Headless K080850 Wright Medical Technology Inc. Compression Screw Biomet BioDrive Cannulated K082874 Biomet Screw System Inion Freedomscrew K123672 Inion OY Description CREED™ Cannulated Screws c…	Biomet Trauma	2009	—
*	K123672	Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) Summary page 4 …K080850 Wright Medical Technology Inc. Compression Screw Biomet BioDrive Cannulated K082874 Biomet Screw System Inion Freedomscrew K123672 Inion OY Description CREED™ Cannulated Screws consists of subject components that will be avai…	Inion OY	2013	—

Also cleared against K160304: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K223847	CREED™ Cannulated Screws	Glw, Inc.	2023	0
K221489	Artemis Proximal Femoral Nail System	Glw, Inc.	2022	0

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 41 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
5 of the 40 ancestors have a recall of any class.
Of its descendants, K223847 (Glw, Inc., 2023) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K160304.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?

CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures, comminuted fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, non-unions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.

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

https://510kreport.com/device/K200291 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200291: CREED™ Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200291

Report an extraction error

Are you the manufacturer?

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