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General product and regulatory information for laboratory, clinic and supply staff. This page is not medical advice and does not describe how any procedure is performed.
Short answer
An arthroscopic shaver is a powered surgical instrument system used in joint arthroscopy to shave, burr, cut and resect tissue. In an FDA clearance record for one such system, it consists of a control unit, a footswitch, a handpiece and accessories, and is classified as Class II under 21 CFR 888.1100 (product code HRX).
Definition and scope
FDA’s regulation for arthroscopes, 21 CFR 888.1100, defines an arthroscope as "an electrically powered endoscope intended to make visible the interior of a joint" and adds that "the arthroscope and accessories also is intended to perform surgery within a joint." Powered shaver systems are cleared under this regulation: the FDA 510(k) database lists the Eberle Shaver System C3 and Accessories (K193608, Eberle GmbH & Co. KG, decision date 2021-01-15) under product code HRX, the product code titled "Arthroscope," with regulation number 888.1100 and device class 2.
The clearance summary for that system describes it as a powered instrument system designed for arthroscopy surgical procedures like shaving, burring, cutting and resecting of fibrous tissue. That wording matters for vocabulary: shaving and burring are functions of the powered system, not separate regulatory device types. For background on the specialty, see what orthopedics is, and for the optical side of arthroscopy, what an endoscope is.
How a powered shaver system is used in practice
The parts named in the clearance summary are a control unit, a footswitch, a handpiece and accessories. A peer-reviewed bench study in the Journal of Orthopaedic Surgery and Research (Liang et al., 2020, PMC7033941) states that arthroscopic shavers play an indispensable role in arthroscopic debridement. It compared two shaver blade designs on resection torque, on tensile and torsional strength of the joint part, and on corrosion resistance using the boiling-water test based on ISO 13402. The authors found no significant difference in resection torque between the two blades tested, but a significantly higher failure load for one design’s joint part.
This page does not cover operating technique. Surgical use is governed by the manufacturer’s instructions for use and by the operating clinician.
Related arthroscopy terms and their FDA categories
People searching for a shaver often meet neighbouring terms. The table maps each one only to what the FDA regulation text and product-code records state.
| Term | What the FDA source says | Source |
|---|---|---|
| Arthroscope and camera system | Electrically powered endoscope to visualise the interior of a joint; Class II (performance standards) | 21 CFR 888.1100(a), (b)(1) |
| Powered shaver system | Cleared under product code HRX, regulation 888.1100, Class II (example: K193608) | FDA 510(k) database, product classification HRX |
| Accessories, arthroscopic | Product code NBH, regulation 888.1100, Class 1 | openFDA classification record |
| Cannulae and depth-gauge kit for arthroscopic procedures | Product code PPR, regulation 888.1100, Class 2 | openFDA classification record |
| Arthroscopic knot pusher | "Suture knotpushers" are listed among manual arthroscopic instruments that are Class I and exempt from premarket notification, subject to the limitations in 888.9 | 21 CFR 888.1100(b)(2) |
| Arthroscopic scissors | The manual-instrument list names knives, punches, graspers, forceps and rongeurs; scissors are not named in the list | 21 CFR 888.1100(b)(2) |
| Arthroscopic burr | Burring is named as a function of the powered shaver system in the K193608 summary; rasps and gouges appear in the manual list | 21 CFR 888.1100; K193608 |
| Arthroscopy pump | Fluid pumps are not named in 888.1100; their category depends on their own clearance record | 21 CFR 888.1100 |
The Class I list in paragraph (b)(2) covers manual instruments: cannulas, curettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods and trocars. A powered shaver is not on that list, which is why a shaver and a manual knot pusher can sit in different FDA classes even though both are called arthroscopy instruments.
Where it matters for labs, clinics and supply decisions
Three record checks follow directly from the sources above. They describe documents to look for, not a buying recommendation.
- Find the product code and regulation. A powered shaver system should trace to a 510(k) number, a product code (HRX in the example record) and 21 CFR 888.1100. A manual instrument listed in (b)(2) is Class I and exempt from premarket notification, so no 510(k) number is expected for it.
- Check reprocessing documentation for reusable designs. FDA’s classification entry for HRX states that validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission if the device is reusable and has specific design features (Table 2 of 82 FR 26807). The manufacturer’s instructions for use are where reprocessing steps appear.
- Note GMP status. The HRX entry lists GMP exempt as "No," so quality system requirements apply to manufacturers of devices under this code.
For how clearance differs from approval, see FDA clearance vs approval and 510(k) vs PMA. For another orthopedic consumable with its own regulatory path, see orthopedic sutures.
Common misunderstandings
Shaver versus burr
The clearance summary lists shaving and burring together as functions of one powered system, so shaving and burring are best read as functions within a powered system rather than separate device categories. Check the specific product labelling.
Shaver versus camera
Both fall under 888.1100, which defines the arthroscope as an electrically powered endoscope and extends to the arthroscope and accessories used for surgery within a joint. The camera provides visualisation; the shaver system is the powered cutting instrument.
All arthroscopy instruments share one class
They do not. The regulation itself splits Class II (the arthroscope) from Class I exempt manual instruments, and the product-code records show Class 1 for NBH and Class 2 for PPR under the same regulation number.
FAQ
What is an arthroscopic shaver?
A powered instrument system with a control unit, footswitch, handpiece and accessories, designed for shaving, burring, cutting and resecting fibrous tissue during arthroscopy (FDA 510(k) K193608).
What FDA class is an arthroscopic shaver?
The cleared example record, product code HRX under 21 CFR 888.1100, is Class II.
Is an arthroscopic knot pusher regulated the same way?
No. Suture knotpushers are listed in 888.1100(b)(2) as Class I manual instruments exempt from premarket notification, subject to 888.9 limitations.
What are arthroscopy instruments?
The regulation’s manual list names cannulas, curettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods and trocars, alongside the powered arthroscope and its accessories.
Sources
- 21 CFR 888.1100, Arthroscope, checked 2026-10-30: law.cornell.edu/cfr/text/21/888.1100 (eCFR: ecfr.gov)
- FDA Product Classification database, product code HRX, checked 2026-10-30: accessdata.fda.gov; NBH and PPR records via openFDA, checked 2026-10-30: open.fda.gov
- FDA 510(k) K193608, Eberle Shaver System C3 and Accessories, checked 2026-10-30: FDA 510(k) database
- Liang P, et al. Assessment of arthroscopic shavers: a comparison test of resection performance and quality. J Orthop Surg Res. 2020, checked 2026-10-30: PMC7033941
