Chrysalis Intelligence · Sponsors · Miach Orthopaedics, Inc.

Miach Orthopaedics, Inc.

Westborough, MA, US · 3 510(k) clearances · 2 recalls

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Total clearances

3

2020-12-16 → 2026-01-13

Last 12 months

1

Product codes

1

Most recent

2026-01-13

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
QNI	Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair	Class II	Orthopedic	3	2026-01-13

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2025-12-31

Date	Severity	Status	Recall #	Product	Code	Reason
2025-12-31	Class II	Ongoing	Z-1220-2026	BEAR Implant. Model Number: 1000.	—	Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be in…
2023-02-02	Class II	Ongoing	Z-0479-2026	BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;	—	The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

Filings

All 510(k) clearances (3)

Date	K-number	Device	Code	Class	Specialty
2026-01-13	K251214	BEAR® (Bridge-Enhanced ACL Restoration) Implant	QNI	Class II	Orthopedic
2025-03-06	K243578	BEAR® (Bridge-Enhanced ACL Restoration) Implant	QNI	Class II	Orthopedic
2020-12-16	DEN200035	BEAR (Bridge-Enhanced ACL Repair) Implant	QNI	Class II	Orthopedic