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510(k) K123619

INTRABLOCK BIOBALL HIP SYSTEM (IBS) by Merete Medical GmbH — Product Code LZO

K123619 is an FDA 510(k) premarket notification submitted by Merete Medical GmbH for the device "INTRABLOCK BIOBALL HIP SYSTEM (IBS)". The FDA issued a decision of Substantially Equivalent on May 24, 2013. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Merete Medical GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2013
Date Received
November 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Merete Medical GmbH

  • K160548 — MC-Subtalar(TM) II (April 29, 2016)
  • K152187 — MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Mer (February 12, 2016)
  • K151762 — PediatrOS RigidTack/FlexTack (December 28, 2015)
  • K142451 — OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod Syste (February 9, 2015)
  • K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD (November 21, 2014)
  • K140069 — LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3. (April 7, 2014)
  • K132226 — METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT (August 9, 2013)
  • K130400 — MERETEC CS, CORTICAL SCREWS (April 5, 2013)
  • K120787 — MERETE LOCKING BONE PLATE SYSTEM III (November 27, 2012)
  • K120978 — OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR (May 2, 2012)

Other clearances for product code LZO

  • K261009 — MobileLink Acetabular Cup System – 40mm ID Inserts (various) (July 6, 2026)
  • K260831 — Z1 Hip System (June 16, 2026)
  • K260182 — Avenir® Müller Stem; Avenir Complete™ Hip System (April 27, 2026)
  • K260037 — implantcast Packaging System Update (March 30, 2026)
  • K252401 — implaFit® short stems (March 12, 2026)
  • K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (January 15, 2026)
  • K250450 — Coated hip implants (September 19, 2025)
  • K243021 — Longboard Revision Hip Stem (August 7, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)

FDA data resources