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510(k) Data Aggregation
K Number
K984200Device Name
STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE
Manufacturer
Date Cleared
1999-01-21
(58 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
R. THOMAS GROTZ, M.D., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stabilizer Soft Tissue Anchor is a titanium alloy implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Device Description
The Stabilizer Soft Tissue Anchor is a titanium alloy (Ti 6A1-4V ELI Alloy for Surgical Implant Applications per ASTM F136-92) implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. The Stabilizer is 8 mm in diameter. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Stabilizer placement is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and optionally securing the ACL to the implanted anchor by using three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures to the implant site if required during the implantation procedure.
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K Number
K973031Device Name
STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE
Manufacturer
Date Cleared
1997-11-03
(81 days)
Regulation Number
890.3490Why did this record match?
Applicant Name (Manufacturer) :
R. THOMAS GROTZ, M.D., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stabilizer Soft Tissue Anchor is a stainless steel implant intended for use as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Device Description
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Stabilizer placement is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and optionally securing the ACL to the implanted anchor by using up to three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures, as may be required, to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer, and to prepare the Stabilizer for entry into the predrilled hole. If sutures are not used, use of the crimper is optional.
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K Number
K965111Device Name
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
Manufacturer
Date Cleared
1997-02-18
(60 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
R. THOMAS GROTZ, M.D., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stabilizer Soft Tissue Anchor is intended for use with USP Sutures as an attachment means for soft tissue and bone for the indications listed below: Shoulder (Bankart repair, SLAP lesion repair, Acromioclavicular separation, Rotator cuff repair, Capsule shift \capsulolabral reconstruction, Biceps tenodesis, Deltoid repair), Elbow (Tennis elbow repair, Biceps tendon reattachment, Medial and lateral repairs), Ankle (Lateral instability, Medial instability, Achilles tendon repair/ reconstruction), Knee (Extra-capsular repairs and attachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament and joint capsule to tibia, joint capsule closure to the anterior proximal tibia; Extra-capsular reconstruction, ITB tenodesis; Patellar ligament and tendon avulsions repairs)
Device Description
The Stabilizer Soft Tissue Anchor is a 316L Stainless Steel implant designed to provide an attachment means for soft tissue to bone using USP grade surgical sutures in joint reconstruction procedures. It is available in two sizes: 5 and 8 mm diameter. Attachment is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and securing soft tissue to the implanted anchor by using three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer and to prepare the stabilizer for entry into the predrilled hole.
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K Number
K964927Device Name
STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8
Manufacturer
Date Cleared
1997-02-07
(60 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
R. THOMAS GROTZ, M.D., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Device Description
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Stabilizer placement is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and securing the ACL to the implanted anchor by using three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer, and to prepare the Stabilizer for entry into the predrilled hole.
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