Medshape, Inc.

Atlanta, GA, US

MEDSHAPE, INC. appears in FDA device records in Atlanta, GA. FDA records list 22 510(k) clearances between 2009-03-25 and 2026-03-18, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 22
PMA records: 0
Recall records: 3
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Medshape, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Medshape Solutions, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 22 510(k) clearances for Medshape, Inc. between 2009 and 2026. The busiest year on record is 2009, with 3. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Medshape, Inc., by decision year
Year	Clearances
2009	3
2010	1
2011	2
2012	1
2013	3
2014	2
2017	1
2018	1
2019	1
2020	1
2021	1
2022	2
2024	1
2025	1
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K254110	DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro	HWC	Substantially Equivalent	2026-03-18
K250628	DynaNail TTC Fusion System	HSB	Substantially Equivalent	2025-09-12
K240530	DynaNail Mini Tapered Hybrid	HWC	Substantially Equivalent	2024-03-21
K220812	DynaClip® Bone Staple	JDR	Substantially Equivalent	2022-08-19
K203595	DynaFuse Fixation System	HWC	Substantially Equivalent	2022-01-04
K203381	Dynanail Mini Hybrid	HWC	Substantially Equivalent	2021-01-15
K193305	DynaClip Bone Staple	JDR	Substantially Equivalent	2020-04-23
K182677	DynaNail Mini	HWC	Substantially Equivalent	2019-02-14
K181781	DynaClipTM Bone Staple	JDR	Substantially Equivalent	2018-11-05
K171376	DynaNail TTC Fusion System	HSB	Substantially Equivalent	2017-11-02
K141420	FASTFORWARD	HTN	Substantially Equivalent	2014-12-18
K141290	HELICAL RIDGE PEEK INTERFERENCE SCREW	HWC	Substantially Equivalent	2014-09-29
K132783	EXOSHAPE DUO SOFT TISSUE FASTENER	MBI	Substantially Equivalent	2013-12-09
K130467	POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE	MBI	Substantially Equivalent	2013-12-05
K123350	ECLIPSE SOFT TISSUE FASTENER	MBI	Substantially Equivalent	2013-03-07
K113828	DYNANAIL ANKLE ARTHRODESIS NAIL	HSB	Substantially Equivalent	2012-02-29
K101934	DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000	HSB	Substantially Equivalent	2011-08-03
K111471	EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)	MBI	Substantially Equivalent	2011-06-10
K101808	SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER	HWC	Substantially Equivalent	2010-11-08
K092914	WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES	MBI	Substantially Equivalent	2009-12-09
K091202	WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,	HWC	Substantially Equivalent	2009-09-16
K083792	WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055	HWC	Substantially Equivalent	2009-03-25

Registered establishments

FDA registered establishments for Medshape, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3007593722	3007593722	MEDSHAPE, INC.	1575 NORTHSIDE DR NW STE 440, Atlanta, GA 30318 US	2026	FSM FZX GAT HSB HTN HTW HWC HXC JDR JDS and 5 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2513-2025	Medshape Universal Joints, REF: DNE-9000-UJ	Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.	Class II	2025-06-02	Open, Classified
Z-0453-2022	DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile	The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.	Class II	2021-11-17	Open, Classified
Z-1276-2013	ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.	Expiration date on the patient label and date on the product carton were not the same.	Class II	2013-04-04	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain