510(k) · Cleared
ClearedCurvtek TSR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolectron, Inc. · HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Cleared on Oct 31, 1997 as substantially equivalent to K885229 (Romano Surgical Instrumentation, Inc., 1989) and 3 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Oct 31, 1997
- Review
- 88 days
- Class
- Class I
- Product code
- HSZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K880074 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880074 Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-BitsRomano Surgical Instrumentation, Inc. · 1988
- This deviceK972860 Curvtek TSR SystemBiolectron, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880074 | Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-Bits | Romano Surgical Instrumentation, Inc. | 1988 | — |
| 0 (this device) | K972860 | Curvtek TSR System | Biolectron, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K885229 | Modified Glenoid Arcuate Drill & Disp. Flexi-BitsSummary page 1…l instruments/systems/devices: Romano Modified Glenoid Arcuate Drill Romano Glenoid Arcuate Bone Drill & Disposable Flexi-Bit Units Hall Series 3 Drill and Micro 100 K 885229 K 880074 * MicroAire Power Master and Series 2000 Pneumatic Power Instrument System ~ * 3M Maxidniver 1l Synthes Compact Air D… | 1989 |
| * | K880074 | Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-BitsSummary page 1…ents/systems/devices: Romano Modified Glenoid Arcuate Drill Romano Glenoid Arcuate Bone Drill & Disposable Flexi-Bit Units Hall Series 3 Drill and Micro 100 K 885229 K 880074 * MicroAire Power Master and Series 2000 Pneumatic Power Instrument System ~ * 3M Maxidniver 1l Synthes Compact Air Drive Il… | 1988 |
| * | K932307 | 3M Maxi-Driver II Dbattery Powered SystemSummary page 1…3 Drill and Micro 100 K 885229 K 880074 * MicroAire Power Master and Series 2000 Pneumatic Power Instrument System ~ * 3M Maxidniver 1l Synthes Compact Air Drive Il K 932307 K 971544 * Do not appear to be in FDA database, could be pre-amendment devices. 6-1 notification2_070997 510(k… | 1994 |
| * | K971544 | Synthes (Usa) Compact Air Drive II (Cad II)Summary page 1…nd Micro 100 K 885229 K 880074 * MicroAire Power Master and Series 2000 Pneumatic Power Instrument System ~ * 3M Maxidniver 1l Synthes Compact Air Drive Il K 932307 K 971544 * Do not appear to be in FDA database, could be pre-amendment devices. 6-1 notification2_070997 510(k) Summary… | 1997 |
| * | — | Hall Series 3 Drill and Micro 100 Named without a submission number | |
| * | — | MicroAire Power Master and Series 2000 Pneumatic Power Instrument System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
How does its category compare?
All HSZ devicesHSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSZ
FDA has decided no HSZ device since 2007.
Median 510(k) review, days · HSZ
Too few HSZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HSZ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSZ
4in 2025
MAUDE reports naming product code HSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 111 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 1 | 411 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 27 |
| 2017 | 0 | — | 0 | 24 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (227 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972860: Curvtek TSR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972860
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026