Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and
Summary
Corin, Ltd. received 510(k) clearance for Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads, a LZO device. Cleared on 2021-07-28.
Details
Source
510(k) Clearance
External ID
K201657
Action Date
2021-07-28
Status
Traditional
Category
device
Product Code
LZO
Product Description
Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads. Product code: LZO.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Corin, Ltd. has 18 FDA actions in our database, including 17 recalls and 1 clearance.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Corin, Ltd. have FDA actions?
Corin, Ltd. has 18 FDA actions in our database, including 17 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K201657" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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