510(k) · Cleared

Cleared

Osstaple, Ossplate, Ossforce

K061385510(k) TraditionalCleared May 30, 2007377-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomedical Enterprises, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 30, 2007 as substantially equivalent to K062181 (Medicrea Technologies, 2007) and 1 other predicate after a 377-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.

Decided: May 30, 2007
Review: 377 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K010911 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
2 generations backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
1 generation backK062181 C-Jaws Cervical Compressive Mini FrameMedicrea Technologies · 2007
This deviceK061385 Osstaple, Ossplate, OssforceBiomedical Enterprises, Inc. · 2007
Descendant · cites it directly · 0 of its ownK073500 Active Anterior Cervical Plate SystemSanacor · 2008

Most influential descendants

Showing 1 of 1 · See all

K073500Active Anterior Cervical Plate SystemSanacor · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K010911	Macropore OS Spinal System	Macropore Biosurgery, Inc.	2001	—
−2	K021039	Bowti Anterior Buttress Staple System	Depuyacromed	2002	—
−1	K062181	C-Jaws Cervical Compressive Mini Frame	Medicrea Technologies	2007	—
0 (this device)	K061385	Osstaple, Ossplate, Ossforce	Biomedical Enterprises, Inc.	2007	—
+1	K073500	Active Anterior Cervical Plate System	Sanacor	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K061385, 2001–2008Source: 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 KWQ? 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 KWQ device

#1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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? (2)

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
*	K062181	C-Jaws Cervical Compressive Mini Frame Cleared while this submission was under review Summary page 2 …ice. e. Substantial Equivalence: The OSStapleTM Staple System is substantially equivalent to the Medicrea C-JAWS Cervical Compressive Mini Frame (K062181) and the Depuy BOWTITM Anterior Buttress Staple (K021039) The FDA has classified these equivalent devices as Class II devices…	Medicrea Technologies	2007	—
*	K021039	Bowti Anterior Buttress Staple System Summary page 2 …e OSStapleTM Staple System is substantially equivalent to the Medicrea C-JAWS Cervical Compressive Mini Frame (K062181) and the Depuy BOWTITM Anterior Buttress Staple (K021039) The FDA has classified these equivalent devices as Class II devices (e.g. 21 CFR, 888.3060). The OSStapleTM Staple System is…	Depuyacromed	2002	—

Also cleared against K062181: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073500	Active Anterior Cervical Plate System	Sanacor	2008	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 6 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K073500 (Sanacor, 2008) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K062181.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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	27	101	2	288
2008	32	70	33	348
2009	23	90	35	355
2010	23	104	2	691
2011	22	95	5	415
2012	26	90	7	544
2013	22	88	6	796
2014	17	124	0	546
2015	25	102	2	562
2016	15	121	9	502
2017	20	67	8	492
2018	22	95	1	341
2019	26	81	0	298
2020	26	55	0	400
2021	17	59	0	591
2022	18	85	0	392
2023	16	59	0	320
2024	17	64	0	419
2025	7	64	0	248
2026	10	76	0	—

What is it indicated for?

For use in conjunction with traditional rigid fixation in cervical fusion procedures as a means to maintain the relative position of bony tissue such as allografts or autografts. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device. This device is not intended to be used alone for load bearing applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061385 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061385: Osstaple, Ossplate, Ossforce.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061385

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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