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Volkmann Retractor: Prongs, Sharp vs Blunt and FDA Class

What a Volkmann retractor is, how catalogue variants differ, and where it sits in FDA classification (GAD, 21 CFR 878.4800), with a listing checklist.

Written and maintained by CASRAI Editorial Board

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General product information only. This page is not medical advice and does not describe how to perform any procedure.

Short answer

A Volkmann retractor is a hand-held surgical retractor with a curved, pronged blade and a handle, used to hold back skin, muscle, soft tissue or bone so the operating field stays exposed. In US regulation it falls under the general “Retractor” product code GAD (21 CFR 878.4800, Class I, exempt from premarket notification). Catalogue entries differ mainly by prong count, sharp or blunt prongs, curve and length.

Definition and scope

The International Committee of the Red Cross and IFRC Standard Products Catalogue lists a “Retractor, general, sharp/blunt prongs, Volkmann” and describes its purpose as retracting “skin, muscles, soft tissues or bones to provide good exposure during surgery.” Its specification reads “hand retractors with hollow handle, single or multiple (3 or 4) prongs, either sharp or blunt” (catalogue page marked as no longer updated; last updated 31 December 2018).

In the US device record system, a reusable Volkmann retractor listed by one manufacturer (N S Surgical Company, “Volkmann Retractor 1 Prong Sharp”) is described in the FDA’s AccessGUDID database as a hand-held, non-self-retaining instrument that separates or draws aside the margins of a wound or incision to allow access during open surgery. That description belongs to the global medical device nomenclature term 45918, “Hand-held surgical retractor, reusable”. For the wider family of retractors, see what a surgical retractor is.

How it is used in practice

Two sources describe use in general terms. The ICRC catalogue gives the purpose quoted above. A UK instrument supplier, Surgical Holdings, describes the Volkmann retractor as having “a comfortable handle and a curved blade with multiple sharp or blunt prongs”, typically made of stainless steel, used in orthopaedic procedures “to gently separate tissues and maintain a clear operating field” (supplier description, not a regulator statement). The FDA record calls it “non-self-retaining”. For another named retractor design, see the Alexis retractor and Langenbeck retractor guides. Technique is a matter for surgical training and is outside this page.

Prong count, sharp and blunt

The ICRC catalogue lists five Volkmann variants. The single sharp prong version is labelled there as a “bone retractor”.

Catalogue variant Prongs Tip Length Prong curve
1 sharp prong 1 Sharp 22 cm 20 mm
3 sharp prongs 3 Sharp 22 cm 10 mm
4 sharp prongs 4 Sharp 22 cm 10 mm
3 blunt prongs 3 Blunt 22 cm 10 mm
4 blunt prongs 4 Blunt 22 cm 10 mm

Source: ICRC/IFRC Standard Products Catalogue, Volkmann retractor entry. Other suppliers list other lengths; Surgical Holdings, for example, lists 220 mm and 245 mm. The ICRC specification gives the material as austenitic steel and says each item is individually packed, with the packaging showing the designation and the supplier’s name and address.

FDA class and device record

This is the part most catalogue pages leave out.

  • Product code: FDA’s product classification database lists code GAD as “Retractor”, Class 1, regulation number 878.4800, “Manual surgical instrument for general use.”
  • Regulation: 21 CFR 878.4800 defines a manual surgical instrument for general use as “a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.” Retractors are among the devices it covers. It is Class I (general controls) and exempt from premarket notification, subject to the limitations in 21 CFR 878.9.
  • Naming: FDA’s classification page for GAD does not use the name Volkmann. The eponymous name comes from manufacturers and catalogues, which is why it appears in records such as AccessGUDID under the manufacturer’s brand name.
  • Reuse and sterility (one manufacturer’s record): the AccessGUDID entry above marks the device as reusable, not supplied sterile, and requiring sterilization before use. This describes that one product; it is not a rule for every Volkmann retractor.

For how device identifiers work, see unique device identification; for what counts as a device in the first place, what is a medical device.

Where it matters for labs, clinics and supply decisions

Three sourced points matter when comparing listings. First, prong count, tip (sharp or blunt), curve and length together define the variant; a listing that gives only “Volkmann retractor” does not say which one it is. Second, the ICRC specification treats designation and supplier name and address as required packaging markings. Third, the reuse and sterility status is a property of each product record: the AccessGUDID example is reusable and non-sterile on delivery, so reprocessing applies, which is covered in medical device reprocessing. The ICRC catalogue page itself makes no statement on sterilization or reuse, so a catalogue spec alone should not be read as answering that question.

Catalogue-reading checklist

  • Prong count (the ICRC lists 1, 3 and 4).
  • Sharp or blunt prongs.
  • Prong curve and overall length.
  • Material (the ICRC lists austenitic steel).
  • Packaging marks: designation and supplier name and address (ICRC).
  • Whether the record states reusable or single-use, and sterile or non-sterile (a regulator database record such as AccessGUDID states this; the ICRC page does not).

Common misunderstandings

“Volkmann” is an FDA device category. It is not: FDA files it under the general retractor code GAD. All Volkmann retractors are the same. The ICRC list alone shows five variants. Class I means no rules. Class I devices are still subject to general controls; the exemption concerns premarket notification only. Reusable means ready to use. The AccessGUDID record above says sterilization is needed before use.

FAQ

What is a Volkmann retractor?

A hand-held surgical retractor with a handle and a curved blade carrying one or more sharp or blunt prongs, used to retract skin, muscle, soft tissue or bone (ICRC/IFRC catalogue).

What is the FDA class of a Volkmann retractor?

Retractors fall under product code GAD, Class I, 21 CFR 878.4800, exempt from premarket notification subject to 21 CFR 878.9. FDA’s page does not name the Volkmann design specifically.

Is a Volkmann retractor reusable?

One manufacturer’s AccessGUDID record (DI G25009006010) states it is reusable and not sterile as supplied. Check the record for the specific product.

What is the difference between sharp and blunt prongs?

The ICRC catalogue lists both tip types in 3-prong and 4-prong versions and a single sharp-prong version it labels a bone retractor; it does not define the difference further.

Sources

  • eCFR, 21 CFR 878.4800 Manual surgical instrument for general use, ecfr.gov, checked 2026-10-30.
  • FDA Product Classification, code GAD (Retractor), accessdata.fda.gov, checked 2026-10-30.
  • NLM AccessGUDID, Volkmann Retractor 1 Prong Sharp (DI G25009006010), N S Surgical Company, accessgudid.nlm.nih.gov, checked 2026-10-30.
  • ICRC/IFRC Standard Products Catalogue, retractor general sharp/blunt prongs Volkmann (XSINMEDI223), itemscatalogue.redcross.int, checked 2026-10-30.
  • Surgical Holdings, Volkmann retractor (supplier description), surgicalholdings.co.uk, checked 2026-10-30.

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