Atlas FDA

ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS

FDA 510(k) clearance K082527 · decided 2008-12-18

Clearance details

K-number
K082527
Device name
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2008-09-02
Decision date
2008-12-18
Days to decision
107 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Zimmer

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Xpert Ankle (K261511)Newclip Technics2026-07-28
Versalock Proximal Tibial Plating System (K261406)GM Dos Reis Industria e Comercio Ltda.2026-07-21
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) (K262032)TriMed, Inc.2026-07-16
Alians Elbow S (K261191)Newclip Technics2026-07-08
RibPlate System (K261054)Stryker Leibinger GmbH & Co KG2026-07-01
SALGINA 2.5mm Distal Radius System (K261351)Bonebridge AG2026-06-26
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (K260958)I.T.S. GmbH2026-06-16
Exalta Proximal Tibia Plating System (K261207)Tyber Medical, LLC2026-06-12
APTUS Clavicle System 2.8 (K260761)Medartis AG2026-06-05
Pectus Blu System (K261002)Biomet Microfixation2026-06-02
Xpert PFP (K261038)Newclip Technics2026-05-29
Avanti Distal Elbow ORIF System (K261145)Avanti Orthopaedics, LLC2026-05-09

Recalls involving this device

RecordFirmDate
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493 recall (Z-1675-2016)Zimmer Manufacturing B.V.2016-05-16
Product 6 consists of all products under product code HWC, and same usage: Item no: 474935 recall (Z-1104-2016)Zimmer Manufacturing B.V.2016-03-12
2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT recall (Z-1041-2014)Zimmer, Inc.2014-02-20
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 COR recall (Z-1044-2014)Zimmer, Inc.2014-02-20

PMA approvals by this applicant

RecordFirmDate
NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095)Zimmer, Inc.2025-08-18
NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093)Zimmer, Inc.2025-04-09
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13