510(k) · Cleared

Cleared

Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System

K001354510(k) TraditionalCleared Mar 13, 2001319-day reviewClass II21 CFR 888.3030

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

Biomedical Ent., Inc. · JDR Staple, Fixation, Bone

Cleared on Mar 13, 2001 after a 319-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.

Decided: Mar 13, 2001
Review: 319 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 0

28 later devices descend from it, 7 citing it directly.

This deviceK001354 Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment…Biomedical Ent., Inc. · 2001
Descendant · cites it directly · 13 of its ownK142292 Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · Recalled
Descendant · cites it directly · 4 of its ownK122871 Compressyn StapleDallen Medical, Inc. · 2013
Descendant · 2 generations on · 3 of its ownK193305 DynaClip Bone StapleMedShape, Inc. · 2020
Descendant · cites it directly · 3 of its ownK170923 JAWS (TM) Nitinol Staple SystemParagon 28 · 2017 · Recalled
Descendant · 2 generations on · 3 of its ownK132875 Compressyn StapleDallen Medical, Inc. · 2013

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2002high 3 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 28 · See all

K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · cites it directly13descendants
K122871Compressyn StapleDallen Medical, Inc. · 2013 · cites it directly4descendants
K193305DynaClip Bone StapleMedShape, Inc. · 2020 · 2 generations on3descendants
K170923JAWS (TM) Nitinol Staple SystemParagon 28 · 2017 · cites it directly3descendants
K132875Compressyn StapleDallen Medical, Inc. · 2013 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001354	Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for…	Biomedical Ent., Inc.	2001	—
+1	K142292	Speed, Speed Shift, Speed Titan, Speed Arc	Biomedical Enterprises, Inc.	2014	3
+1	K122871	Compressyn Staple	Dallen Medical, Inc.	2013	—
+2	K193305	DynaClip Bone Staple	MedShape, Inc.	2020	—
+1	K170923	JAWS (TM) Nitinol Staple System	Paragon 28	2017	1
+2	K132875	Compressyn Staple	Dallen Medical, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2007	1	0
2013	2	0
2014	3	0
2015	1	0
2017	2	0
2018	3	0
2019	1	0
2020	2	0
2022	2	0
2023	3	0
2024	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K001354, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDR? 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 JDR device

#1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K142292	Speed, Speed Shift, Speed Titan, Speed Arc	Biomedical Enterprises, Inc.	2014	13
K122871	Compressyn Staple	Dallen Medical, Inc.	2013	4
K170923	JAWS (TM) Nitinol Staple System	Paragon 28	2017	3
K071477	Reverto 55 and 37 Shape Memory Staples	Core Essence Orthopaedics, LLC	2007	1
K023488	Osstaple, Craniofacial	Biomedical Enterprises, Inc.	2002	0
K023486	Osstaple, Maxillofacial	Biomedical Enterprises, Inc.	2002	0
K023203	Osstaple	Biomedical Ent., Inc.	2002	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?

Of its descendants, K142292 (Biomedical Enterprises, Inc., 2014) has gone furthest, with 13 descendants of its own.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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	8	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

https://510kreport.com/device/K001354 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001354

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026