Straight answers about the blood-based PRP shot

Sources

1. The devices used to spin PRP at the point of care are cleared by FDA as clinical centrifuges, product code JQC, a Class I device under 21 CFR 862.2050 - for example the Biomet GPS Platelet Separation Kit (K030555, cleared 2003) and the Harvest SmartPrep2 / SmartPrep Platelet Concentration System (K103340, cleared 2010). That clearance covers the equipment that separates blood. It is not an FDA approval of platelet-rich plasma as a treatment for osteoarthritis, tendinopathy or any other orthopedic condition, and copy must never blur the two.

   U.S. Food and Drug Administration (Center for Devices and Radiological Health) — 510(k) Premarket Notification database and Product Classification: JQC, Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, 21 CFR 862.2050. FDA accessdata (CDRH device databases), 2003.

2. FDA states verbatim of stem cell, stromal vascular fraction, umbilical cord blood, Wharton's jelly, amniotic fluid and exosome products: 'None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.' The only FDA-approved stem cell products in the United States are blood-forming cells from umbilical cord blood, approved only for disorders of blood production, and there are no FDA-approved exosome products. PRP is a different product from all of these and the categories must not be blurred in either direction.

   U.S. Food and Drug Administration — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. FDA (Center for Biologics Evaluation and Research), 2020.

3. Medicare's national coverage policy covers autologous platelet-rich plasma ONLY for patients with chronic non-healing diabetic, pressure and/or venous wounds, and only within an approved coverage-with-evidence-development clinical study. There is no Medicare national coverage for PRP in osteoarthritis or tendinopathy, which is why these injections are billed to the patient as cash-pay.

   Centers for Medicare & Medicaid Services — Autologous Platelet-rich Plasma (Coverage with Evidence Development). CMS.gov, 2024.

4. In the RESTORE trial - the largest placebo-controlled PRP trial in knee osteoarthritis - 288 adults aged 50+ with symptomatic Kellgren-Lawrence grade 2-3 medial knee OA received three weekly intra-articular injections of leukocyte-poor PRP from a commercial system or saline placebo. At 12 months the mean change in knee pain was -2.1 points with PRP versus -1.8 with saline (difference -0.4; 95% CI -0.9 to 0.2; P=.17) against a minimum clinically important difference of 1.8, and the change in medial tibial cartilage volume was -1.4% versus -1.2% (difference -0.2%; 95% CI -1.9% to 1.5%; P=.81). Twenty-nine of 31 prespecified secondary outcomes showed no significant between-group difference. The authors concluded the findings do not support use of PRP for knee OA.

   Bennell KL, Paterson KL, Metcalf BR, et al. — Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial. JAMA, 2021. DOI: 10.1001/jama.2021.19415.

5. A systematic review of 105 clinical PRP studies in orthopaedics published 2006-2016 found that only 11 (10%) described the preparation protocol clearly enough for another investigator to repeat it, and only 17 (16%) reported any quantitative metric of the final PRP composition. The authors concluded that the current reporting of PRP preparation and composition does not allow the PRP products actually delivered to patients to be compared between studies.

   Chahla J, Cinque ME, Piuzzi NS, et al. — A Call for Standardization in Platelet-Rich Plasma Preparation Protocols and Composition Reporting: A Systematic Review of the Clinical Orthopaedic Literature. Journal of Bone and Joint Surgery (American), 2017. DOI: 10.2106/JBJS.16.01374.

6. The ESSKA-ICRS consensus applied the RAND/UCLA appropriateness method to 216 clinical scenarios for intra-articular PRP in knee OA. Only 84 scenarios (38.9%) were rated appropriate, 9 (4.2%) inappropriate and 123 (56.9%) uncertain. PRP was judged appropriate in patients aged 80 or under with KL grade 0-III osteoarthritis AFTER failed conservative non-injective or injective treatment; it was NOT considered appropriate as a first treatment, nor in KL grade IV (bone-on-bone) osteoarthritis, where 91.7% and 87.5% of scenarios respectively were uncertain.

   Kon E, de Girolamo L, Laver L, et al. — Platelet-rich plasma injections for the management of knee osteoarthritis: The ESSKA-ICRS consensus. Recommendations using the RAND/UCLA appropriateness method for different clinical scenarios. Knee Surgery, Sports Traumatology, Arthroscopy, 2024. DOI: 10.1002/ksa.12320.

7. A systematic review and meta-analysis of adverse events in randomized trials of intra-articular PRP for knee osteoarthritis found PRP associated with mild, transient adverse events - knee pain and swelling - that typically resolve without intervention, and more frequent with LEUKOCYTE-RICH formulations. Leukocyte-poor PRP had a safety profile similar to hyaluronic acid. Knee stiffness was more frequent with PRP than with normal saline (P=.031). No severe adverse events were reported in any group.

   Nakagawa HF, Kim J, Rabinowitz J, et al. — Assessment of adverse events and safety associated with intra-articular platelet-rich plasma injections compared to other injectates for knee osteoarthritis: A systematic review and meta-analysis. PM&R, 2026. DOI: 10.1002/pmrj.70141.