Company ยท US
Acumed LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2025. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (0 in 12 months)
51recalls (1 in 12 months)
48recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 40 |
| HRS | Plate, Fixation, Bone | 26 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 5 |
| HTN | Washer, Bolt Nut | 4 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 3 |
| LXH | Orthopedic Manual Surgical Instrument | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| JDQ | Cerclage, Fixation | 1 |
| JDW | Pin, Fixation, Threaded | 1 |
| JEC | Component, Traction, Invasive | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2025 | K252356 | The Acumed Wrist Fixation System - 2.4mm Screws Acumed, LLC | HRS |
| Jul 14, 2025 | K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws Acumed, LLC | HRS |
| Jun 18, 2025 | K251296 | The Acumed Wrist Fixation System Acumed, LLC | HRS |
| Jan 23, 2025 | K243624 | Acu-Sinch Knotless Mini Acumed, LLC | HTN |
| Apr 22, 2024 | K233311 | Acumed Wrist Plating System Acumed, LLC | HRS |
| Jun 9, 2023 | K230744 | Acumed Acutrak 3 Headless Compression Screw System Acumed, LLC | HWC |
| Dec 29, 2022 | K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional Acumed, LLC | HWC |
| Jan 7, 2022 | K212990 | Acumed Ankle Syndesmosis Repair System Acumed, LLC | HTN |
| Jul 15, 2021 | K210750 | Acumed Clavicle Hook Plating System Acumed, LLC | HRS |
| Oct 30, 2015 | K151886 | Acumed Ankle and Small Fragment Base Set Update Acumed, LLC | HRS |
| Apr 6, 2015 | K143385 | Acumed Ankle Plating System Acumed, LLC | HRS |
| Feb 5, 2015 | K143276 | Acumed Small Bone IM Nail System Acumed, LLC | HSB |
| Jan 23, 2015 | K143394 | Acumed Small Fragment Base Set Acumed, LLC | HRS |
| Jun 13, 2014 | K141383 | ACUMED HAND FRACTURE SYSTEM Acumed, LLC | HRS |
| May 20, 2014 | K140925 | ACUMED SUTURE ANCHOR SYSTEM Acumed, LLC | MBI |
| Mar 10, 2014 | K133469 | ACUMED SUTURE ANCHOR SYSTEM Acumed, LLC | MBI |
| Jan 6, 2014 | K132769 | ACUMED HAND PLATING SYSTEM Acumed, LLC | HRS |
| Oct 10, 2013 | K131636 | POLARUS CONNECT Acumed, LLC | LXT |
| Sep 30, 2013 | K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC Acumed, LLC | KWI |
| Sep 5, 2013 | K131764 | ACUMED WRIST SPANNING PLATE Acumed, LLC | HRS |
| Jul 23, 2013 | K130986 | FRAG-LOC SYSTEM Acumed, LLC | HTN |
| Jun 10, 2013 | K131380 | ACUMED TOTALW RIST FUSION PLATING SYSTEM Acumed, LLC | HRS |
| Mar 18, 2013 | K123890 | ACUMED CANNULATED SCREW SYSTEM Acumed, LLC | HWC |
| Nov 19, 2012 | K122538 | ACUMED PELVIC BONE PLATE SYSTEM Acumed, LLC | HRS |
| Jul 13, 2012 | K120903 | CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE Acumed, LLC | HRS |
| Nov 14, 2011 | K112111 | ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR Acumed, LLC | HTN |
| Aug 29, 2011 | K111608 | SLIC SCREW REPAIR SYSTEM Acumed, LLC | HWC |
| Jan 4, 2011 | K102998 | CONGRUENT BONE PLATE SYSTEM Acumed, LLC | HRS |
| Oct 6, 2010 | K100123 | ACUMED WRIST ARTHRODESIS PLATE SYSTEM Acumed, LLC | HRS |
| Jun 16, 2009 | K083144 | ACUMED CLAVICLE SCREW SYSTEM Acumed, LLC | JDW |
| Aug 9, 2007 | K071944 | ACUMED SMALL BONE LOCKING SYSTEM II Acumed, LLC | HSB |
| Jul 18, 2007 | K071715 | ACUMED CONGRUENT BONE PLATE SYSTEM Acumed, LLC | HRS |
| Dec 7, 2006 | K063460 | ACUMED CONGRUENT BONE PLATE SYSTEM Acumed, LLC | HRS |
| Jul 21, 2005 | K051410 | ACUMED RIB CONGRIENT BONE PLATE SYSTEM Acumed, LLC | HRS |
| May 12, 2005 | K051083 | ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM Acumed, LLC | HRS |
| Oct 5, 2004 | K041858 | ACUMED ANATOMIC RADIAL HEAD SYSTEM Acumed, LLC | KWI |
| Jan 15, 2004 | K033639 | ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM Acumed, LLC | HWC |
| Jul 17, 2003 | K031438 | ACUMED SMALL BONE LOCKING ROD SYSTEM II Acumed, LLC | HSB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2026 | Acumed LLC Acumed Hexalob Screw various sizes:
REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw;
3070-27009 2.7mm x 9mm NL Hexalobe Screw;
3070-27010 2.7mm x 10mm NL Hexalobe Screw;
3070-27011 2.7mm x 11m Open, Classified |
HRS | K251132 K251296 |
| Feb 29, 2024 | Acumed LLC Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standar Open, Classified |
HRS | None listed |
| Dec 26, 2023 | Acumed LLC RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320
The RBL2320, Low Profile Primary Guide is an instrument used with a power system to
compress the RibLoc plates onto the bone, d Open, Classified |
LXH | None listed |
| Dec 23, 2022 | Acumed LLC Dual-Trak Clavicle Screws
Part Number/Part Description:
40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw
40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw
40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw
40-0 Open, Classified |
HWC | K221333 |
| Dec 23, 2022 | Acumed LLC AcuTwist Acutrak Compression Screws
Part Number/Part Description:
AI-0010-S 10mm AcuTwist Acutrak Compression Screw
AI-0012-S 12mm AcuTwist Acutrak Compression Screw
AI-0014-S 14mm AcuTwist Acutrak Co Open, Classified |
HWC | K221333 |
| Dec 23, 2022 | Acumed LLC Acutrak 2
Part Number/Part Description:
30-0021 25.0mm Acutrak 2 - 5.5 Screw
30-0021-S 25.0mm Acutrak 2 - 5.5 Screw
30-0023 30.0mm Acutrak 2 - 5.5 Screw
30-0023-S 30.0mm Acutrak 2 - 5.5 Screw
30-0025 Open, Classified |
HWC | K221333 |
| Dec 23, 2022 | Acumed LLC Part Number/Part Description:
30-0033-S 30mm Acutrak Fusion Device 6mm Nose
AM-0025-S 25.0mm Acutrak 4/5 Bone Screw
AM-0030-S 30.0mm Acutrak 4/5 Bone Screw
AM-0035-S 35.0mm Acutrak 4/5 Bone Open, Classified |
HWC | K221333 |
| Mar 9, 2022 | Acumed LLC 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 Completed |
HWC | K123890 |
| Mar 9, 2022 | Acumed LLC 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 Completed |
HWC | K123890 |
| Apr 20, 2017 | Acumed LLC The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants Terminated |
KWI | K131845 |
| Mar 16, 2017 | Acumed LLC .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter.
.054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407 Terminated |
LXH | None listed |
| Feb 14, 2017 | Acumed LLC 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and Terminated |
HRS | K122538 |
| Dec 5, 2016 | Acumed LLC OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt. Terminated |
MQV | K042340 |
| Apr 25, 2014 | Acumed LLC The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire.
50.0 Terminated |
HRS | K931244 |
| Apr 25, 2014 | Acumed LLC The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. .
2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S
2.0 mm SS Sleeve Only; Part Number 01-0022-S
8, 7 hol Terminated |
HTY | K964500 |
| Apr 2, 2012 | Acumed LLC The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is label Terminated |
HSB | K951740 |
| Jun 16, 2010 | Acumed LLC Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, U Terminated |
HRS | K012655 |
| May 14, 2010 | Acumed LLC Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR
Intended use: Acumed intramedullary rods and screws are designed to provide Terminated |
HWC | K942340 |
| May 10, 2010 | Acumed LLC Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR Terminated |
HSB | K031438 |
| Mar 16, 2010 | Acumed LLC Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed Terminated |
JEC | K965029 |
| Oct 23, 2009 | Acumed LLC Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320- Terminated |
HWC | K061763 |
| Dec 11, 2008 | Acumed LLC Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 " Terminated |
HSD | K992525 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 9 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Right... REF PL Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Left... REF PL-C Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Small Right ... REF PL-CL8S Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Medium Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Medium Right ... REF PL-CL Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Medium Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Medium Left ... REF PL-CL8M Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Large Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Large Right ... REF PL-CL8L Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes Large Left ... REF PL-CL8LL- Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes, J-Plate Right... REF PL Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 8 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 8 Holes, J-Plate Left... REF PL-C Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 6 Holes Small Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 6 Holes Small Right ... REF PL-CL6S Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 6 Holes Small Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 6 Holes Small Left ... REF PL-CL6SL- Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 10 Holes Large Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 10 Holes Large Right... REF PL-CL1 Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC Locking Clavicle Plate, 10 Holes Large Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 10 Holes Large Left... REF PL-CL10L Terminated |
HWC | K012655 |
| Sep 20, 2008 | Acumed LLC 10mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 10mm Bone Graft Drill... REF BG-8020-S ... LOT W54076". Terminated |
HWC | K960711 |
| Sep 20, 2008 | Acumed LLC 6mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 6mm Bone Graft Drill... REF BG-8006-S ... LOT W51258". Terminated |
HWC | K960711 |
| Sep 20, 2008 | Acumed LLC Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP/MPJ Combo Fusion Plate... REF 70-003 Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036- Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC Right Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP Revision Fusion Plate... REF 70-0019- Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 1st MTP Revision Fusion Plate... REF 70-0018-S. Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Dorsal 1st MTP Fusion Plate... REF 70-0012-S... L Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC Right Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking Proximal Metatarsal Wedge Plate... REF 70-0 Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC Left Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Proximal Metatarsal Wedge Plate... REF 70-001 Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC 4 Hole Locking 2nd and 3rd Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 4 Hole Locking 2nd and 3rd Tarsometatarsal Plate... R Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC 4 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 4 Hole Locking 1st Tarsometatarsal Plate... REF 70-0008-S... L Terminated |
HWC | K033639 |
| Sep 20, 2008 | Acumed LLC 5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 5 Hole Locking 1st Tarsometatarsal Plate... REF 70-0007-S... Terminated |
HWC | K033639 |
| Sep 11, 2008 | Acumed LLC Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System Terminated |
HWC | K012655 K942340 +1 |
| Aug 28, 2008 | Acumed LLC 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed Terminated |
HWC | K942340 |
| Aug 28, 2008 | Acumed LLC Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ". Terminated |
HRS | K012655 |
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