Company · US
Biomet Microfixation, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (1 in 12 months)
62recalls (0 in 12 months)
17recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 17 |
| JEY | Plate, Bone | 15 |
| LZD | Joint, Temporomandibular, Implant | 15 |
| KDD | Kit, Surgical Instrument, Disposable | 9 |
| HWC | Screw, Fixation, Bone | 5 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 3 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 3 |
| LXH | Orthopedic Manual Surgical Instrument | 2 |
| MPL | Mandibular Condyle Prosthesis | 2 |
| NDJ | Screw, Fixation, Bone, Non-Spinal, Metallic | 2 |
| DZL | Screw, Fixation, Intraosseous | 1 |
| ECI | Band, Elastic, Orthodontic | 1 |
| EJL | Bur, Dental | 1 |
| EMG | Forceps, Tooth Extractor, Surgical | 1 |
| EMM | Chisel, Osteotome, Surgical | 1 |
| FDG | Retractor, Fiberoptic | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| GXR | Cover, Burr Hole | 1 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 1 |
| HWR | Driver, Prosthesis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2026 | K261002 | Pectus Blu System Biomet Microfixation | HRS |
| Sep 19, 2024 | K241709 | Pectus Blu Support Bar System Biomet Microfixation | HRS |
| Nov 15, 2022 | K223199 | 2.1 x 255mm Drill, 22mm Stop Biomet Microfixation | HBE |
| May 17, 2022 | K212782 | SternaLock Sternal Closure System Biomet Microfixation | HRS |
| Apr 22, 2022 | K212608 | RibFix Blu Thoracic Fixation System Biomet Microfixation | HRS |
| Mar 11, 2022 | K213712 | Pectus Support Bar System Biomet Microfixation | HRS |
| Dec 23, 2021 | K213208 | Twist Drills Biomet Microfixation | HBE |
| Aug 5, 2021 | K202969 | Biomet Microfixation OmniMax MMF System Biomet Microfixation | JEY |
| Jun 5, 2019 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder Biomet Microfixation | OCV |
| Dec 9, 2016 | K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation | HRS |
| Nov 23, 2016 | K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System Biomet Microfixation | HRS |
| Aug 2, 2016 | K161896 | Biomet Microfixation Sternal Closure System Biomet Microfixation | HRS |
| Mar 24, 2016 | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation | HRS |
| Dec 10, 2015 | K152326 | Biomet Microfixation OmniMax MMF System Biomet Microfixation | JEY |
| Nov 3, 2015 | K151019 | SternaLock® 360 Sternal Closure System Biomet Microfixation | HRS |
| May 26, 2015 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation | HWC |
| Apr 1, 2015 | K143336 | Biomet Microfixation OmniMax MMF System Biomet Microfixation | JEY |
| Feb 25, 2015 | K142823 | Biomet Microfixation Thoracic Fixation System Biomet Microfixation | HRS |
| Oct 2, 2013 | K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING Biomet Microfixation | JEY |
| Aug 8, 2013 | K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING Biomet Microfixation | JEY |
| Jun 17, 2013 | K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM Biomet Microfixation | GXR |
| Oct 12, 2012 | K121624 | BIOMET MICROFIXATION NEURO PLATING SYSTEM Biomet Microfixation | GWO |
| Sep 21, 2012 | K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM Biomet Microfixation | JEY |
| Sep 19, 2012 | K121302 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM Biomet Microfixation | HRS |
| Jun 29, 2012 | K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM Biomet Microfixation | JEY |
| Nov 29, 2011 | K111908 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM Biomet Microfixation, Inc. | HWC |
| May 18, 2011 | K110574 | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM Biomet Microfixation, Inc. | HRS |
| Jul 22, 2009 | K091058 | ADKINS STRUT Biomet Microfixation, Inc. | HRS |
| May 9, 2008 | K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) Biomet Microfixation, Inc. | JEY |
| Sep 6, 2007 | K071577 | BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER Biomet Microfixation, Inc. | HRS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2017 | Biomet Microfixation, LLC Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 Terminated |
HWT | None listed |
| Jun 13, 2016 | Biomet Microfixation, LLC Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made.
HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/d Terminated |
KKY | K924935 |
| Aug 6, 2015 | Biomet Microfixation, LLC Thinflap System Case
The cases hold surgical instrumentation in place during handling and storage. Terminated |
GWO | K121624 |
| Aug 6, 2015 | Biomet Microfixation, LLC Neuro Combo Set Case
The cases hold surgical instrumentation in place during handling and storage. Terminated |
GWO | K121624 |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Terminated |
LZD | None listed |
| Sep 2, 2014 | Biomet Microfixation, LLC Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506
The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally recons Terminated |
LZD | None listed |
| Mar 27, 2012 | Biomet Microfixation, LLC The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device.
Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***ST Terminated |
IRQ | None listed |
| Mar 23, 2012 | Biomet Microfixation, LLC Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM Terminated |
JEY | K953385 |
| Jan 24, 2012 | Biomet Microfixation, Inc. The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades.
The SternaLock Blu Implant Tray would have been found within the following outer containers:
Silver Instr Terminated |
HRS | K110574 |
| Jan 23, 2012 | Biomet Microfixation, Inc. Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE Terminated |
NDJ | K953385 |
| Jan 23, 2012 | Biomet Microfixation, Inc. Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE Terminated |
NDJ | K953385 |
| Jan 20, 2012 | Biomet Microfixation, Inc. The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint Terminated |
MPL | None listed |
| Jan 20, 2012 | Biomet Microfixation, Inc. The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint.
The c Terminated |
MPL | None listed |
| Jan 11, 2012 | Biomet Microfixation, Inc. Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 15 Terminated |
HBF | None listed |
| Oct 5, 2011 | Biomet Microfixation, Inc. Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOME Terminated |
ECI | None listed |
| Aug 1, 2011 | Biomet Microfixation, Inc. "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofix Terminated |
LXH | None listed |
| Jul 22, 2011 | Biomet Microfixation, Inc. "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA* Terminated |
HWC | K953385 |
| Jul 19, 2011 | Biomet Microfixation, Inc. "***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKS Terminated |
KDD | None listed |
| Jul 19, 2011 | Biomet Microfixation, Inc. "***REF: 922090 TMJ SYSTEM InnerVue SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRI Terminated |
KDD | None listed |
| Jul 19, 2011 | Biomet Microfixation, Inc. "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS Distributed by: BIOMET MICROFIXATION 1520 TRADEPORT DRI Terminated |
KDD | None listed |
| Jul 19, 2011 | Biomet Microfixation, Inc. "***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Terminated |
KDD | None listed |
| Jul 11, 2011 | Biomet Microfixation, Inc. Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***www.biometfixation.com***2.0 MM X 7.0 MM TITANIUM***#01-6577***LOT XXXXXX***QTY 00 Terminated |
KBW | None listed |
| May 27, 2011 | Biomet Microfixation, Inc. ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0 Terminated |
JEY | K953385 |
| Oct 20, 2010 | Biomet Microfixation, Inc. 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150.
Product labeling reads:
(1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG.
(2.) QTY 00001, CE 0086, *** Terminated |
JEY | K854886 |
| Sep 9, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS STEEL, NYLON, ***NON-STERILE PRODUCT***. The Rees Insulated Forceps are used during surgery to grasp, dissect a Terminated |
GEN | None listed |
| Aug 11, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK.
BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVIL Terminated |
DZL | K953385 |
| Jun 30, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***.
Bone screws used along with implantable bone pl Terminated |
JEY | K953385 |
| Apr 11, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT.
Part Number SP-1918
BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32 Terminated |
HWR | None listed |
| Mar 17, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TR Terminated |
JEY | K953385 |
| Jan 4, 2010 | Biomet Microfixation, Inc. LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185, NON-STERILE PRODUCT,
BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmic Terminated |
HWC | None listed |
| Jan 4, 2010 | Biomet Microfixation, Inc. LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT,
BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com.
Terminated |
HWC | None listed |
| Dec 16, 2009 | Biomet Microfixation, Inc. Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141.
DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.
A single use Terminated |
HBE | K062842 |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
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