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The FLOW 90 Wand, used with Qualified Controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) - Ablation/ Debrideement - (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar, Tissue, Soft Tissue, Synovectomy, Tendon) - Excision/Resection (Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane,Tendon) Hip - Excision/Resection - (Acetabular Labrum) Knee - Ablation/ Debrideement - (ACL/PCL, Notchplasty) - Excision/Resection - (Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy) Shoulder - Ablation/ Debrideement - (Subacromial Decompression) - Excision/Resection - (Frozen Shoulder Release, Glenoid Labrum) Wrist - Excision/Resection - (Triangular Fibrocartilage)

The FLOW 90 Wand is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. The FLOW 90° Wand is compatible with Qualified controllers (WEREWOLF® COBLATION® Systems (includes WEREWOLF® (K162074), WEREWOLF® ENT, (K192027) and WEREWOLF® + (K210423)) and INTELLIO® SHIFT ® System (K232290)). The FLOW 90 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the Qualified Controller and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the Qualified Controllers to support the use of the modified FLOW 90 Wand.

The INTELLIO SHIFT System is indicated for: - Resection of soft and osseous tissues . - . Resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during the following arthroscopic and orthopedic procedures: | Arthroscopic | | | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Location | Ablation/Debridement | Excision/Resection | | All Joints (Hip,<br>Knee, Shoulder,<br>Wrist, Ankle,<br>Elbow) | Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Synovectomy Tendon | Articular Labrum Capsule Cysts Ligament Loose Bodies Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon | | Hip | N/A | Acetabular Labrum | | Knee | ACL/PCL Notchplasty | Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release Meniscal Cystectomy Meniscectomy Villusectomy | | Shoulder | Subacromial Decompression Acromioplasty | Frozen Shoulder Release Glenoid Labrum | | Wrist | N/A | Triangular Fibrocartilage (TFCC) | | Orthopedic | | | | Hemostasis (via coagulation) of soft tissue and bone | | |

The INTELLIO SHIFT System combines two previously cleared technologies into one system. The INTELLIO SHIFT System is composed of (1) a controller that combines the radio frequency coblation/coagulation technology of the previously cleared (K210423) WEREWOLF+ COBLATION System with the mechanical resection technology of the previously cleared (K062849) DYONICS POWER II Control System and (2) a wired foot pedal that controls these two technologies. The INTELLIO SHIFT System utilizes the same technologies as the predicates and matches the performance requirements of the WEREWOLF+ and DYONICS POWER II controllers. The INTELLIO SHIFT System allows the user to select and operate two established resection technologies using the same device: Mechanical Resection (MR) for cutting and tissue removal, and Bipolar Radio Frequency (RF) for coblation/coagulation. The INTELLIO SHIFT System is compatible with various accessories including RF coblation/coagulation Wands, a Mechanical Resection Motor Drive Unit Handpiece, and a wired foot pedal. The INTELLIO SHIFT System interfaces with a handpiece Motor Drive Unit (MDU) shaver, to provide mechanical cutting and tissue removal. The INTELLIO SHIFT System interfaces with RF Wands to utilize bipolar RF technology for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, and orthopedic procedures. Additionally, the INTELLIO SHIFT System can be interfaced directly with 510K cleared fluid management systems. INTELLIO SHIFT provides an optional interface for the INTELLIO Connected Tower, which is composed of Smith and Nephew equipment typically used in arthroscopic or orthopedic surgical procedures and stored near each other on a single cart. While the INTELLIO SHIFT System provides options to healthcare professionals to use both Mechanical Resection and Coblation/Coagulation through the same device and within the same surgery, these technologies cannot be used at the exact same time.

The ARIS Wand, used with the WEREWOLF COBLATION System, is Indicated for ablation, resection and coaqulation of soft tissue and hemostasis of blood vessels in otorhinolarynqology (ENT) surgery including; nasal airway obstruction of hypertrophic nasal turbinates and submucosal tissue shrinkage.

The ARIS COBLATION Turbinate Reduction Wand (Figure 1) is a single-use, disposable, bipolar, radio frequency, electrosurgical device intended for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue. There are no changes to the WEREWOLF Controllers or Irrigation pump for use with ARIS Wand. The ARIS Turbinate Reduction Wand consists of three integrated lines built into the handpiece that allow the wand to work as intended: - An integrated suction line with universal barb allows connection to suction source within the operating environment. - An integrated saline tube set designed to be compatible with the WEREWOLF controller . pump module allows connection with saline source within the operating environment. - . An integrated cable to be compatible with the WEREWOLF controller.

The Ambient Hip Vac 50 Wand with Integrated Finger Switches is indicated for the resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures: | Joint | Ablation/Debridement | Excision/Resection | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | All Joints (Hip, Knee,<br>Shoulder, Wrist, Ankle,<br>Elbow) | • Articular Cartilage<br>• Bursectomy<br>• Chondroplasty<br>• Fascia<br>• Ligament<br>• Scar Tissue<br>• Soft Tissue<br>• Synovectomy<br>• Tendon | • Articular Labrum<br>• Capsule<br>• Cysts<br>• Ligament<br>• Loose Bodies<br>• Plica Removal<br>• Scar Tissue<br>• Soft Tissue<br>• Synovial Membrane<br>• Tendon | | Hip | | • Acetabular Labrum | | Knee | • ACL/PCL<br>• Notchplasty | • Capsular Release<br>• Cartilage Flaps<br>• Discoid Meniscus<br>• Lateral Release<br>• Meniscal Cystectomy<br>• Meniscectomy<br>• Villusectomy | | Shoulder | • Acromioplasty<br>• Subacromial Decompression | • Frozen Shoulder Release<br>• Glenoidale Labrum | | Wrist | | • Triangular Fibrocartilage (TFCC) |

The Ambient HipVac 50 Wand is a bipolar, high frequency (HF) electrosurgical device designed for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the indicated arthroscopic and orthopedic procedures (K161481). The Ambient HipVac 50 Wand consist of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached to the proximal end of the handle and connect to the Controller and hospital wall suction, respectively. The plastic molded handle includes three integrated finger switches (IFS) used to activate and adjust the Coblation (ablation) and Coagulation modes: CUT (ablation), COAG (coagulation), and set point adjustment. The Ambient feature provides accurate (± 3° C) real-time temperature monitoring of the circulating irrigating fluid between 20°C and includes a user adjustable alarm set point. The Wand is designed for use up to 15 minutes of cumulative active ablation and is currently cleared to be used with ArthroCare System 12000 (QUANTUM II). Alternately, the surgeon can control these functions with the optional foot pedal. The WEREWOLF COBLATION Systems (RF20000, WEREWOLF, WEREWOLF+) consist of a bipolar, radiofrequency (RF) generator (COBLATION System) with Integrated Fluid Module (FLOW IQ Pump) and Operational Interface Screen, Re-usable, non-sterile Foot Control (wired or wireless), Sterile, disposable, single-use COBLATION Wand(s), and Reusable, non-sterile power cord. The systems utilize bipolar technology specifically designed for the resection, ablation, and coagulation of blood vessels in various arthroscopic, orthopedic, and otorhinolaryngology (ENT) procedures. The controllers are enclosed units with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface which the user can control various modes, levels, volume, etc.

WEREWOLF™ FASTSEAL 6.0 Hemostasis Wand: The FASTSEAL 6.0 Wand, used with the WEREWOLF™ + COBLATION System, is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures. WEREWOLF™ + COBLATION™ SYSTEM - See Page 2 The WEREWOLF"+ COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic, orthopedic and otorhinolaryngology [ENT] procedures: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Ablation/Debridement (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon), Excision/Resection (Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon) Hip: Excision/Resection (Acetabular Labrum) Knee: Ablation/Debridement (ACL/PCL, Notchplasty), Excision/Resection (Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy) Shoulder: Ablation/Debridement (Acromioplasty, Subacromial Decompression), Excision/Resection (Frozen Shoulder Release, Glenoid Labrum) Wrist: Excision/Resection (Triangular Fibrocartilage (TFCC)) ENT: Resection/Ablation/Coagulation (Tonsillectomy (including Palatine Tonsils) Tracheal, Adenoidectomy, Uvulopalatopharyngoplasty (UPPP), Traditional Uvulopalatoplasty Control (RAUP), Nasal Airway Obstruction, Submucosal Palatal Shrinkage, Submucosal Tissue Shrinkage, Nasal Airway Obstruction by reduction of Hypertrophic Nasal Turbinates, Reduction of Turbinates for the treatment of Nasal Airway Obstruction, Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Mastoidectomy, Myringotomy with Effective Hemorrhage, Papilloma, Keloids, Nasopharyngeal/Laryngeal Procedures, Polypectomy, Laryngeal Polypectomy, Laryngeal Lesion Debulking, Cysts, Tumors, Neck Mass, Head, Neck, Oral, and Sinus Surgery, Tissue in the Uvula/Soft Palate for the treatment of Snoring) Orthopedic: Hemostasis (via coagulation) of soft tissue and bone.

The subject devices include the WEREWOLF ° + (RF20000) COBLATION System, which includes the WEREWOLF®+Controller and the WEREWOLF® FASTSEAL 6.0 Hemostasis Wand. The subject WEREWOLF + COBLATION System (System) is an iteration of the WEREWOLF Controllers previously cleared via 510(k)s K143235, K162074, K 192027 and K202006 which utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, orthopedic (cleared via K143235 and K162074), and otorhinolaryngology (ENT) procedures (K192027 and K202006). The subject WEREWOLF + COBLATION System consists of: - A bipolar, radiofrequency (RF) generator (WEREWOLF + Controller, subject . Controller) with Integrated Fluid Module (FLOW~IQ Pump), and Operational Interface Screen, - Re-usable, non-sterile Foot Control (wired or wireless) . - . Sterile, disposable, single-use COBLATION Wand(s)/FASTSEAL 6.0 Hemostasis Wand (subject Wand) - Reusable, non-sterile power cord. The components are designed to be operated as a single unit and are for prescription use only. The WEREWOLF+ COBLATION System utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, orthopedic, and otorhinolaryngology (ENT) procedures. The WEREWOLF + Controller is designed to deliver radiofrequency energy to the electrodes of the compatible Wand. The Controller is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface with which the user can control various modes, levels (setpoints), volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel. The subject WEREWOLF FASTSEAL 6.0 Hemostasis Wand is a bipolar, RF electrosurgical device used for specific indications in orthopedic surgeries. The Wand is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures. It is intended for procedures using normal saline (0.9% NaCl) as the irrigation fluid for the Wand.

Subject Device(s) Indications of Use ENT Wands ENT Plasma Wands Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction of hypertrophic nasal turbinates, nasopharyngeal/ laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. Turbinator Wands Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) sinus surgery involving nasal airway obstruction of hypertrophic nasal turbinates and submucosal tissue shrinkage. The Wand is designed to be used exclusively with the COBLATOR II (CII) controller and Irrigation pump or the WEREWOLF COBLATION System (in conjunction with the ENT Adapter and Irrigation Tube Set). Other controllers/pumps must not be used. WEREWOLF ENT Adapter The WEREWOLF ENT Adapter, in conjunction with the Smith & Nephew COBLATOR II Compatible ENT Wands, the Smith & Nephew WEREWOLF COBLATION System and the WEREWOLF Irrigation Tube Set (as needed) are indicated for the ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT/otorhinolaryngology procedures. WEREWOLF Irrigation Tube Set The WEREWOLF Irrigation Tube Set, in conjunction with the Smith & Nephew COBLATOR II Compatible ENT Wands, the Smith & Nephew WEREWOLF COBLATION System and the WEREWOLF ENT Adapter are indicated for the ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT/otorhinolaryngology procedures.

The ENT Plasma Wands (K070374 and K142999) and Turbinator Wand (K122652) are currently cleared to be used with the ArthroCare ENT Coblator Surgery System (COBLATOR II) (K030108). This 510(k) is to obtain clearance for the use of ENT Wands, in conjunction with two accessories, with the recently cleared WEREWOLF COBLATION System (K192027 - Dec 20, 2019). The accessories are the WEREWOLF ENT Adapter and the WEREWOLF Irrigation Tube Set The extended compatibility does not result in any changes to the overall design or to the indications of use for the ENT Wands nor the WEREWOLF COBLATION System. ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for use in ablation, resection and coagulation of soft tissue, and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery. Turbinator Wand is a bipolar, single use, high frequency electrosurgical device designed for use for specific turbinate indications in otorhinolaryngology (ENT) procedures. The WEREWOLF ENT Adapter is a reusable, electrically-activated adapter with an 8pin connector at the distal end an 18-pin connector at the proximal end. The reusable WEREWOLF ENT Adapter is designed to be used with the COBLATOR II Compatible ENT Wands (8-pin connector) and WEREWOLF COBLATION System (18-pin connector), along with the WEREWOLF Irrigation Tube Set, as needed. The WEREWOLF Irrigation Tube Set is a single use, disposable, sterile device. The Irrigation Tube Set is designed to be used with COBLATOR II compatible ENT Wands and WEREWOLF COBLATION System, along with the reusable WEREWOLF ENT Adapter. The spike of the Irrigation Tube Set is connected to an irrigation source for select ENT Wands; that is, the ENT wands that use a conductive media, such as normal saline intraoperatively.

Indications for Use - WEREWOLF™COBLATION™ SYSTEM The WEREWOLF COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following otorhinolaryngology (ENT) procedures: Resection/Ablation/Coagulation - Tonsillectomy (Including Palatine Tonsils) - Adenoidectomy - Uvulopalatopharyngoplasty (UPPP) - Traditional Uvulopalatoplasty (RAUP) - Nasal Airway Obstruction - Submucosal Palatal Shrinkage - Submucosal Tissue Shrinkage - Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates - Reduction of Turbinates for the Treatment of Nasal Airway Obstruction - Nasopharyngeal/Laryngeal Indications Including Tracheal Procedures - Mastoidectomy - Myringotomy with Effective Hemorrhage Control - Papilloma Keloids - Nasopharyngeal/Laryngeal Procedures - Polypectomy - Laryngeal Polypectomy - Laryngeal Lesion Debulking - Cysts - Tumors - Neck Mass - Head, Neck, Oral, and Sinus Surgery - Tissue in the Uvula/ Soft Palate for the Treatment of Snoring Indications for use - COBLATION™ HALO™ Wand The COBLATION HALO Wand, used with the WEREWOLF COBLATION System, is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectory, adenoidectomy, and uvulopalaty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate.

The proposed WEREWOLF COBLATION System consists of: - A bipolar, radiofrequency (RF) generator (Controller) with Integrated Fluid . Module and Operational Interface Screen, - . Re-usable, non-sterile Foot Control (wired or wireless) - Sterile, disposable, single-use COBLATION Wand(s) - . Reusable, non-sterile power cord. The components are designed to be operated as a single unit. The WEREWOLF COBLATION System utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, orthopedic and otorhinolaryngology (ENT) procedures. The proposed Controller is designed to deliver radiofrequency energy to the electrodes of the compatible COBLATION Wand. The Controller is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface with which the user can control various modes, levels, volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed. The Controller also incorporates a peristaltic Integrated Fluid Control Module, which provides dynamic control of saline flow (inflow or outflow) to or from the surgical site. The proposed Controller operates in 5 modes (Lo, Med, Hi, Coag and Vac mode) for arthroscopic and orthopedic procedures and in 4 modes (Lo, Med, Hi and Coag) for the ENT procedures. The proposed HALO Wand is designed to be used exclusively with the proposed WEREWOLF™ COBLATION™ System. The HALO Wand is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectomy, adenoidectomy, and uvulopalatopharyngoplasty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate. The Wands are provided sterile (via ethylene oxide) and are single-use only.

The FLOW 90° Wand, used with the WEREWOLF COBLATION System, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: | Joint | Ablation/Debridement | Excision/Resection | |-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | All Joints<br>(Hip,<br>Knee,<br>Shoulder,<br>Wrist,<br>Ankle,<br>Elbow) | • Articular Cartilage<br>• Bursectomy<br>• Chondroplasty<br>• Fascia<br>• Ligament<br>• Scar Tissue<br>• Soft Tissue<br>• Synovectomy<br>• Tendon | • Articular Labrum<br>• Capsule<br>• Cysts<br>• Ligament<br>• Loose Bodies<br>• Plica Removal<br>• Scar Tissue<br>• Soft Tissue<br>• Synovial Membrane<br>• Tendon | | Hip<br>Knee | • ACL/PCL<br>• Notchplasty | • Acetabular Labrum<br>• Capsular Release<br>• Cartilage Flaps<br>• Discoid Meniscus<br>• Lateral Release<br>• Meniscal Cystectomy<br>• Meniscectomy<br>• Villusectomy | | Shoulder | • Acromioplasty<br>• Subacromial<br>Decompression | • Frozen Shoulder Release<br>• Glenoid Labrum | | Wrist | | • Triangular Fibrocartilage |

The FLOW 90 Wand (Wand) is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Similar to the predicate device FLOW 50 Wand (K162074), FLOW 90 Wand is designed to be exclusively used with WEREWOLF® COBLATION® System (K162074). The FLOW 90 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the WEREWOLF Controller (part of the WEREWOLF Coblation System) and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the WEREWOLF Controller to support the use of the Flow 90 Wand.

The AMBIENT Super MULTIVAC® 50 Wand with Integrated Finger Switches is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures. All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Synovectomy Tendon Knee: ACL/PCL Notchplasty Shoulder: Acromioplasty Subacromial Decompression All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Labrum Capsule Cysts Ligament Loose Bodies Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon Hip: Acetabular Labrum Knee: Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release Meniscal Cystectomy Meniscectomy Villusectomy Shoulder: Frozen Shoulder Release Glenoidale Labrum Wrist: Triangular Fibrocartilage (TFCC) All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Cartilage Ligament Tendon Knee: ACL/PCL Medial Retinaculum Shoulder: Glenohumeral Capsule Rotator Cuff Wrist: Carpal Ligaments Wrist Tendons

The AMBIENT Super MULTIVAC° 50 Wand with Integrated Finger Switches ("Wand") is a bipolar, high frequency electrosurgical device used for specific indications in orthopedic and arthroscopic surgeries. The AMBIENT feature provides accurate (± 3° C) real-time temperature monitoring of the circulating irrigating fluid between 20° C and includes a user adjustable alarm set point. The Wand is designed for use up to five minutes of cumulative active ablation time at the default set point of 7 and is to be used only with the QUANTUM® 2 Controller ("Controller").

The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for: Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction Hip: Acetabular labral repair

The Q-Fix Suture Anchor (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. This family of suture anchors previously was available in two sizes, 1.8mm and 2.8mm. This submission proposes an additional size of Q-Fix Suture Anchor, the 1.8mm Q-Fix MINI Suture Anchor. The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only. The Q-Fix Suture Anchor consists of the bone anchor and associated instruments for implanting the bone anchor.