“FDA Approved” or “FDA Cleared”? What Many in Orthopedics Get Wrong

If you're in the orthopedic or spine space—whether you're a surgeon, distributor, product manager, or startup founder—you’ve probably used the phrase “FDA approved” to describe a product.

But chances are… you got it wrong.

Even seasoned professionals regularly misuse regulatory terms when discussing total joints, spinal implants, demineralized bone matrix (DBM), and tissue-based products.

Important Note: This article is not a comprehensive regulatory guide, nor is it intended as legal advice. For specific decisions, consult with a qualified regulatory professional or attorney.

This is a high-level explainer to help non-regulatory professionals use the right language—and avoid costly mistakes.

PART 1: How the FDA Classifies Medical Devices

1. Class I, II, and III Devices—What’s the Difference?

The FDA classifies medical devices based on risk level and regulatory burden:

• Class I (Low Risk): Basic tools like manual surgical instruments. → Often exempt from premarket review by the FDA. Testing usually limited to biocompatibility or bench safety, if any.

• Class II (Moderate Risk): Most orthopedic and spinal implants (e.g., interbody cages, screws, fixation plates). → Require mechanical or performance testing, such as fatigue, torsion, and simulated use models.

• Class III (High Risk): Devices that support or sustain life, or are new and high-risk (e.g., innovative total hip systems, novel implants). → Require clinical trials, long-term data, and robust FDA review through the PMA process.

2. “FDA Approved” vs. “FDA Cleared”

Let’s demystify this once and for all:

• FDA Cleared = The product passed through the 510(k) pathway, which clears it for commercial marketing. → Must prove it’s substantially equivalent to a legally marketed predicate device. → Typically involves mechanical or simulation testing, not clinical trials.

• FDA Approved = The product passed through the Premarket Approval (PMA) pathway. → Reserved for Class III devices. → Requires clinical data demonstrating safety and effectiveness and a thorough FDA review.

·       🔍 Industry Myth: Most interbody cages and fixation systems are not “FDA approved.” They’re typically Class II and cleared via the 510(k) process.

PART 2: Understanding Tissue Products and Biologics

1. What is an HCT/P?

HCT/P stands for Human Cells, Tissues, and Cellular and Tissue-Based Products.

These include:

• DBM (demineralized bone matrix)

• Cancellous Chips

• Allograft Cervical Spacers

• Acellular dermis

• Amniotic membranes

If an HCT/P meets all criteria under Section 361 of the Public Health Service Act, it's regulated under 21 CFR Part 1271—a lower regulatory burden focused on preventing communicable disease.

No 510(k), no PMA, and no FDA “approval” or “clearance” in this case—just registration of the tissue processing facility and adherence to tissue bank standards.

2. When Is a Tissue Product Regulated More Like a Device or Drug?

If a tissue-based product:

• Is more than minimally manipulated

• Is used for a non-homologous function

• Or is combined with a drug, device, or synthetic component

…it likely no longer qualifies as a 361 HCT/P. Instead, it becomes regulated as a:

• Device (often requiring a 510(k) if a predicate exists)

• Biologic (requiring IND/BLA)

🧠 Example: A DBM that includes only processed allograft may qualify as a 361 tissue product. But add a synthetic carrier—like a hydrogel, polymer, or bioactive compound—and it now requires 510(k) clearance as a medical device if there is a predicate acceptable to the FDA.

3. Common Mistakes in Tissue Product Terminology

• “Our all tissue DBM is FDA approved.” → ❌ No—it may be a 361 HCT/P, which is neither approved nor cleared.

• “FDA cleared DBM putty.” → ✅ Correct—if it includes a synthetic or device-like carrier and has gone through the 510(k) pathway.

• “This amnion product is 510(k) cleared.” → ❌ Unlikely since amnion tissues don’t have an established predicate for a 510(k).

• “We are FDA registered.” → ✅ That refers to tissue establishment registration—not product-level clearance or approval.

CONCLUSION: Precision in Language Reflects Precision in Practice

If you’re selling, marketing, using, or evaluating biologics and implants in spine or orthopedics, you should know:

• Whether the product is a medical device, a 361 HCT/P, or a biologic drug

• What type of FDA review (if any) it underwent

• Which testing—bench, animal, clinical—was required to reach market

In a field where regulatory misstatements can bring FDA scrutiny or lawsuit exposure, getting the terminology right isn’t just academic. It’s strategic.

Let’s stop blurring the lines. Let’s raise the standard.

Let’s connect → Kevin Armstrong – Black Swan 360