ClearanceBrief
Panels › Orthopedic › Product code JDR · Class 2

Staple, Fixation, Bone

Regulation 888.3030

2510(k)s in 12 months (233 all time)
2recalls in 12 months (37 all time)
35recalls that name a 510(k)
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Top companies in JDR

DateFirm and productCodeLinked 510(k)
Sep 17, 2026F & A Foundation
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-4090
Open, Classified
JDRNone listed
Jun 8, 2026In2bones USA, LLC
NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 S
Open, Classified
JDRK161426
Oct 18, 2022Synthes (USA) Products LLC
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Open, Classified
JDRK191463
Oct 18, 2022Synthes (USA) Products LLC
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Open, Classified
JDRK142292
Oct 18, 2022Synthes (USA) Products LLC
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Open, Classified
JDRK142292
Oct 18, 2022Synthes (USA) Products LLC
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and re
Open, Classified
JDRK142292
Oct 6, 2022Synthes (USA) Products LLC
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Open, Classified
JDRK191463
Mar 10, 2022Wright Medical Technology, Inc.
EasyFuse Dynamic Compression System Instrument Pack
Terminated
JDRK203832
Feb 14, 2022Biomet, Inc.
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X
Terminated
JDRNone listed
Feb 14, 2022Biomet, Inc.
BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient re
Terminated
JDRK111663
Feb 14, 2022Biomet, Inc.
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT].
Terminated
JDRK133939
Feb 14, 2022Biomet, Inc.
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch,
Terminated
JDRK141263
Jan 18, 2022Merete Medical GmbH
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Terminated
JDRK151762
Sep 25, 2020Stryker GmbH
Osteosynthesis Compression Staple EasyClip
Open, Classified
JDRK122113
Nov 14, 2018In2bones USA, LLC
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Terminated
JDRK161426
Apr 13, 2018TriMed Inc.
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
Terminated
JDRK112794
Apr 13, 2018TriMed Inc.
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
Terminated
JDRK112794
Apr 13, 2018TriMed Inc.
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Terminated
JDRK112794
Apr 13, 2018TriMed Inc.
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Terminated
JDRK112794
Dec 19, 2017Paragon 28, Inc.
P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
Terminated
JDRK170923
Mar 20, 2017Crossroads Extremity Systems Llc
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Terminated
JDRK142727
Jan 25, 2017Integra LifeSciences Corp.
The UNI-CP System; Model Number: 330230SND.
Terminated
JDRK011716
Dec 23, 2015Stryker Howmedica Osteonics Corp.
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Terminated
JDRK031127
Apr 2, 2015Biomet, Inc.
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
Terminated
JDRK080088
K101063
Apr 2, 2015Biomet, Inc.
ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intende
Terminated
JDRK130033
K141263
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2013Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor
Terminated
JDRK082215
Sep 17, 2008DePuy Mitek, Inc., a Johnson & Johnson Co.
Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor
Terminated
JDRK070925
Aug 2, 2006Boston Scientific Corp
Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog no. 820-103, UPN M0068201030.
Terminated
JDRK932925
Aug 2, 2006Boston Scientific Corp
Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000).
Terminated
JDRK932925

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