Atlas FDA

PROFEMUR HIP SYSTEM MODULAR NECKS

FDA 510(k) clearance K100866 · decided 2010-04-28

Clearance details

K-number
K100866
Device name
PROFEMUR HIP SYSTEM MODULAR NECKS
Applicant
Wrightmedicaltechnologyinc
Decision
Substantially Equivalent
Date received
2010-03-29
Decision date
2010-04-28
Days to decision
30 days
Clearance type
Special
Product code
LZO
Device class
2
Regulation number
888.3353
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Arlington, TN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Wrightmedicaltechnologyinc

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
MobileLink Acetabular Cup System – 40mm ID Inserts (various) (K261009)Waldemar Link GmbH & Co. KG2026-07-06
Z1 Hip System (K260831)Zimmer, Inc.2026-06-16
Avenir® Müller Stem; Avenir Complete™ Hip System (K260182)Zimmer, Inc.2026-04-27
implantcast Packaging System Update (K260037)Implantcast GmbH2026-03-30
implaFit® short stems (K252401)Implantcast GmbH2026-03-12
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (K253171)Maxx Orthopedics, Inc.2026-01-15
Coated hip implants (K250450)Medacta International S.A.2025-09-19
Longboard Revision Hip Stem (K243021)Signature Orthopaedics Pty, Ltd.2025-08-07
Z1 Hip System (K251906)Zimmer, Inc.2025-07-18
RECLAIM Monobloc Revision Femoral Stem (K251292)Depuy Ireland UC2025-05-23
MobileLink Acetabular Cup System - inhouse coatings (K243927)Waldemar Link GmbH & Co. KG2025-05-16
NEXUS® Hip Stem (K250444)Microport Orthopedics, Inc.2025-05-15

Recalls involving this device

RecordFirmDate
PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Num recall (Z-2948-2020)MicroPort Orthopedics Inc.2020-09-09
Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF recall (Z-0683-2017)MicroPort Orthopedics Inc.2016-12-01
Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF recall (Z-0684-2017)MicroPort Orthopedics Inc.2016-12-01
Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF P recall (Z-0685-2017)MicroPort Orthopedics Inc.2016-12-01
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 3 recall (Z-0686-2017)MicroPort Orthopedics Inc.2016-12-01
Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF recall (Z-0687-2017)MicroPort Orthopedics Inc.2016-12-01
Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, R recall (Z-0688-2017)MicroPort Orthopedics Inc.2016-12-01
Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 2600002 recall (Z-0689-2017)MicroPort Orthopedics Inc.2016-12-01
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 1 recall (Z-2743-2015)MicroPort Orthopedics, Inc.2015-09-28

PMA approvals by this applicant

RecordFirmDate
ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL (P960057/S011)Wrightmedicaltechnologyinc2000-09-27
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S004)Wrightmedicaltechnologyinc1999-08-11
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S008)Wrightmedicaltechnologyinc1999-06-02
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S006)Wrightmedicaltechnologyinc1999-04-21
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S005)Wrightmedicaltechnologyinc1999-03-18
ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S003)Wrightmedicaltechnologyinc1999-01-14
ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S002)Wrightmedicaltechnologyinc1998-11-25
ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057/S001)Wrightmedicaltechnologyinc1998-09-11