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CITREPORE™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CITREPORE is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. CITREPORE is intended to be used for filling bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, CITREPORE resorbs and is replaced with bone during the healing process.

CITREPORE™ is a synthetic, highly porous, resorbable bone void filler fabricated from a polymer bioceramic composite comprised of 60 wt.-% polymer and 40 wt.-% ASTM F1538 4555 Bioactive Glass. The polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. Bioactive Glass is a biologically compatible synthetic material consisting of silicates, sodium oxides, and phosphates. The constituent materials (citrate, Ca, P, O, H, Si) exist naturally in normal bone. CITREPORE is provided to the end user in a variety of shapes and sizes that facilitates new bone formation across the graft site and throughout the interconnected porous structure. CITREPORE is pliable and sponge-like and can be cut to fit the bony defect using traditional instruments that are available in the OR at the time of surgery. At the time of surgery, CITREPORE can be infused with autologous blood, bone marrow aspirate, and/or other fluids. As body fluids penetrate the device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites. Upon implantation, the Bioactive Glass component of CITREPORE undergoes a surface modification that provides for direct bonding to surrounding bone via an apatite layer (i.e., bioactive). CITREPORE is single use and provided sterile. MATERIALS: POC (poly-octamethylene-citrate) and ASTM F1538 4555 Bioactive Glass.

The CITRELOCK® DUO is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically: Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The CITRELOCK® DUO is a two-piece design consisting of a cannulated, self-locking, CITRELOCK® implant made from CITREGEN® biomaterial coupled with an eyelet component made from PEEK. The CITRELOCK® DUO system consists of fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm. The purpose of this Special 510(k) Device Modification is to advise the FDA of this line extension wherein an eyelet to accommodate suture was added to the previously 510(k) cleared CITRELOCK® "twist-ribbed", cannulated, self-locking bone anchor. The CITRELOCK® DUO device utilizes the same correspondingly sized and designed primary predicate, the CITRELOCK®, with the added PEEK eyelet at the tip of the device. These two components are sterile packaged together and mounted on a Cartridge that facilitates loading onto the Inserter instrument. The CITRELOCK® DUO is made from CITREGEN® biomaterial, which is a resorbable, homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxyapatite (HA) and 40 wt.-% polyester. CITREGEN's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites. The eyelet is made from polyether ether ketone (PEEK) conforming to ASTM F2026. Suture material is not provided with the device.

The Citrespline™ and Citrelock™ ACL Implants are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist. The Citregen Tendon Interference Screw and CitreLock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist.

The subject devices are comprised of CITREGEN biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxyapatite (HA) and 40 wt.-% polyester. CITREGEN'S polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites. The CITREGEN™ Tendon Interference Screw (TIS) and CITRELOCK™ Tendon Fixation Device are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm. There are two designs: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. Citregen TIS and Citrelock implants attach soft tissue to bone for surgical procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist. Select single use manual instruments are packaged together with an implant in a sterile "kit" configuration (Xpress Kit). There is an additional subset of sterile single use instruments to facilitate surgery (Prep Kit). Alternatively, there is a set of reusable instruments. THE CITRESPLINE™ and CITRELOCK™ ACL Implants are bone anchor devices ranging in diameter from 7 to 12 mm in 1 mm increments, and lengths of 23, 28, and 33 mm. There are two designs for the system: 1) "twist-ribbed" cannulated, self-locking devices (CITRELOCK ACL) and 2) a "straight spline" style device (CITRESPLINE). Both designs have a cannula through the central axis for alignment into the surgically prepared site. Surgical placement is facilitated with a reusable set of instruments.

The Citregen Tendon Interference Screw and CitreLock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist. The Acuitive Citrefix Knotless Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder foot ankle, knee, hand/wrist and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction. The Citrespline ACL and Citrelock ACL are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically: Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

This 510(k) notification advises FDA of minor changes to implant specifications, revisions and additions to the class 1 instruments, and an extension of shelf life to three years per the original validation plan presented in K200725. The subject bone anchor devices are comprised of Citregen biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxyapatite (HA) and 40 wt.-% polyester. Citregen's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites. The following paragraphs describe the subject devices. The Citregen Tendon Interference Screw and Citrelock are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm. There are two designs; 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock) that is inserted into bone. Citregen Tendon Interference Screw and Citrelock implants attach soft tissue to bone for surgical procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist. The updates to the class 1 manual instruments include minor design modifications and new reusable instruments, single-use and sterile instruments that are packaged together with an implant in a "kit" configuration and new single-use and sterile instruments to facilitate surgery. The Citrefix is a suture anchor offered in diameters between 2.9 and 5.5 mm and lengths ranging between 12.5 and 24.0 mm, and includes an integral eyelet made of PEEK that facilitates passage of suture through the tip of the anchor. The Citrefix is implanted with reusable instruments that include size specific drills and awls for preparing the bone, and an insertion instrument for placement of the Citrefix device. Suture is not provided with the Citrefix device. The Citrespline ACL and Citrelock ACL are bone anchor devices ranging in diameter from 7 to 12 mm in 1 mm increments, and lengths of 23, 28, and 33 mm. There are two designs for the system: 1) "twist-ribbed" cannulated, self-locking devices (Citrelock ACL) and 2) a "straight spline" style device (Citrespline ACL). Both designs have a cannula through the central axis for alignment into the surgically prepared site. Surgical placement is facilitated with a reusable set of instruments.

The Citrespline™ and Citrelock™ ACL Implants are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The CITRESPLINE™ and CITRELOCK™ ACL Implants are soft tissue fixation devices ranging in diameter from 7 to 12 mm in 1 mm increments, and lengths of 23, 28, and 33 mm. There are two designs for the system: 1) a "twist-ribbed" cannulated, self-locking device (trade names CITRELOCK ACL and CITRELOCK) and 2) a "straight spline" style device (trade name CITRESPLINE). Both designs include a cannula through the central axis to allow for alignment into the surgically prepared site. Like the predicate devices, surgical placement of the implants in bone is facilitated with a reusable set of instruments. The CITRESPLINE and CITRELOCK ACL Implants are intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist. The CITRESPLINE and CITRELOCK ACL Implants are made from CITREGEN biomaterial, which is a homogeneous biocomposite comprised of 60 wt. -% unsintered hydroxyapatite (HA) and 40 wt.-% polyester. CTREGEN's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.

The Acuitive CITREFIX™ Knotless Suture Anchor is intended for fixation of suture to bone in the shoulder foot/ankle, knee, hand/wrist and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achiles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction. Metatarsal Ligament Repair/Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

The CITREFIX Knotless Suture Anchor is comprised primarily of Acuitive Technologies' proprietary CITREGEN, citrate-based polymer / bioceramic composite material. An integral eyelet made of PEEK conforming to ASTM F2026 facilitates passage of the suture through the tip of the anchor. The CITREFIX device is offered in diameters between 2.9 and 5.5 mm and lengths ranging between 12.5 and 24.0 mm. The CITREFIX Knotless Suture Anchor is implanted with reusable instruments, which include size specific drill and awl options for preparing the bone and an insertion instrument for placement of the CITREFIX device. Suture is not provided with the CITREFIX device. The CITREFIX Knotless Suture Anchor is made from CITREGEN biomaterial, a homogeneous biocomposite of 60 % unsintered hydroxyapatite (HA) and 40 % polyester. CITREGEN's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer occurs through hydrolysis of ester bonds located between the monomers and at crosslink sites.

The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The Citregen TIS and Citrelock are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm to be used with reusable instruments. There are two designs for the system: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. The Citregen TIS and Citrelock system is intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist. The Citregen TIS and Citrelock are made from Citregen biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxvapatite (HA) and 40 wt.-% polyester. Citregen's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.