# K972860: Curvtek TSR System

- Pathway: 510(k) (Traditional)
- Applicant: Biolectron, Inc.
- Decided: Oct 31, 1997 after 88 days
- Product code: HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880074 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885229: Modified Glenoid Arcuate Drill & Disp. Flexi-Bits, Romano Surgical Instrumentation, Inc. (1989) Summary page 1.
- K880074: Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-Bits, Romano Surgical Instrumentation, Inc. (1988) Summary page 1.
- K932307: 3M Maxi-Driver II Dbattery Powered System, 3M Health Care, Ltd. (1994) Summary page 1.
- K971544: Synthes (Usa) Compact Air Drive II (Cad II), Synthes (Usa) (1997) Summary page 1.
- (no number) Hall Series 3 Drill and Micro 100: named in the summary without a submission number
- (no number) MicroAire Power Master and Series 2000 Pneumatic Power Instrument System: named in the summary without a submission number

## Indications for use
The intended use of the CurvTek TSR System is substantially equivalent to the predicate devices listed in this 510(k) application. The device is to be used to drill holes in bone, except for cranio and maxifacial bones, for soft tissue attachment, or wiring/cabling as in the following techniques: Soft Tissue Repair Techniques Shoulder Bankart Lesion Repair Capsular Shift/Capsulorrhaphy SLAP Lesion Repair Magnuson and Stack Repair Rotator Cuff Repair Knee Five-in-One Knee Repair Capsule Repair/ Capsulorrhaphy Triad Knee Repair Quadriceps Femoris Tendon Repair Patellar Tendon Repair Hip Reattach Gluteus Medius Take-Down Capsule Repair/ Capsulorrhaphy Adductor Longus & Gracilis Transfer External Oblique Transfer Iliopsoas Tendon Transfer Limb Salvage Forearm/Wrist/Hand Reattachment Upper Arm Reattachment Foot Reattachment Lower Leg/Ankle Reattachment Thigh Reattachment Elbow Fascia Lata Ligament Reconstruction Flexorplasty Bicepts Tenodesis Triceps Tendon Repair Ulnar or Radial Collateral Ligament Repair Hand and Wrist Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Volar Plate Reconstruction Triangular Fibro-Cartilage Ligament Repair Soft Tissue Repair Techniques (Con’t.) Foot & Ankle Bunionectomy Collateral Ligaments Repair PT Tendon Advancement Achilles Tendon Repair Attachment of Distal EHL at Hallux IPJ Urological Repair Retropubic urethral suspension Bladder neck suspension Wiring/Cabling Techniques Spine Cervical Cabling Lumbar Cabling Osteotomy of Cervical Spine Arthrodesis, Lateral Transverse Process Trauma For 3 Part Fracture of Humeral Head Treatment of Sternoclavicular Dislocation Repair For Olecranon Fractures Treatment of Open Patellar Fracture Midfoot Reconstruction

Source page: https://510kreport.com/device/K972860
Methodology: https://510kreport.com/methodology