Chrysalis Intelligence · Sponsors · Acumed, LLC

Acumed, LLC

Hillsboro, OR, US · 9 510(k) clearances · 9 recalls

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Total clearances

9

2021-07-15 → 2025-08-21

Last 12 months

0

Product codes

3

Most recent

2025-08-21

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
HRS	Plate, Fixation, Bone	Class II	Orthopedic	5	2025-08-21
HTN	Washer, Bolt Nut	Class II	Orthopedic	2	2025-01-23
HWC	Screw, Fixation, Bone	Class II	Orthopedic	2	2023-06-09

Safety

Recalls (9)

Class I (serious)

0

Risk of injury / death

Total recalls

9

Currently ongoing

7

Most recent

2026-05-28

Date	Severity	Status	Recall #	Product	Code	Reason
2026-05-28	Class II	Ongoing	Z-2532-2026	Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL…	—	Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
2023-12-19	Class II	Ongoing	Z-1218-2024	Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Lef…	—	Distribution without Pre-Market Clearance
2023-11-27	Class II	Ongoing	Z-0618-2024	RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an …	—	Due to potential breakage during use.
2022-11-29	Class II	Ongoing	Z-0770-2023	Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm…	—	Distribution without Pre-Market Clearance
2022-11-29	Class II	Ongoing	Z-0769-2023	AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw …	—	Distribution without Pre-Market Clearance
2022-11-29	Class II	Ongoing	Z-0768-2023	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…	—	Distribution without Pre-Market Clearance
2022-11-29	Class II	Ongoing	Z-0767-2023	Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bo…	—	Distribution without Pre-Market Clearance
2022-03-09	Class II	Completed	Z-0959-2022	4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012	—	Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal …
2022-03-09	Class II	Completed	Z-0958-2022	4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010	—	Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal …

Filings

All 510(k) clearances (9)

Date	K-number	Device	Code	Class	Specialty
2025-08-21	K252356	The Acumed Wrist Fixation System - 2.4mm Screws	HRS	Class II	Orthopedic
2025-07-14	K251132	The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws	HRS	Class II	Orthopedic
2025-06-18	K251296	The Acumed Wrist Fixation System	HRS	Class II	Orthopedic
2025-01-23	K243624	Acu-Sinch Knotless Mini	HTN	Class II	Orthopedic
2024-04-22	K233311	Acumed Wrist Plating System	HRS	Class II	Orthopedic
2023-06-09	K230744	Acumed Acutrak 3 Headless Compression Screw System	HWC	Class II	Orthopedic
2022-12-29	K221333	Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional	HWC	Class II	Orthopedic
2022-01-07	K212990	Acumed Ankle Syndesmosis Repair System	HTN	Class II	Orthopedic
2021-07-15	K210750	Acumed Clavicle Hook Plating System	HRS	Class II	Orthopedic