Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Paragon 28 with 61 510(k) clearances and 13 device recalls. The most recent is a 510(k) clearance dated Oct 7, 2026: APEX 3D S Diamond Tibia.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 7, 2026 | APEX 3D S Diamond TibiaK261120 · HSN | 510(k) clearances |
| Aug 28, 2026 | Primal K-Wire (P99-193-1410)K262722 · HTY | 510(k) clearances |
| Aug 6, 2026 | Megalodon Dynamic Compression SystemK261121 · JDR | 510(k) clearances |
| Aug 3, 2026 | Grappler Suture Anchor SystemK262047 · MBI | 510(k) clearances |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implantClass III · Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contrib | Device recalls |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implantClass III · Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contrib | Device recalls |
| Jun 17, 2026 | P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1Class II · Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. | Device recalls |
| Mar 17, 2026 | Grappler Suture Anchor PCFD Tether SystemK253886 · MBI | 510(k) clearances |
| Mar 5, 2026 | Phantom® Hindfoot TTC/TC Nail SystemK253591 · HSB | 510(k) clearances |
| Dec 19, 2025 | Monkey Rings External Ring Fixation SystemK253613 · KTT | 510(k) clearances |
| Oct 13, 2025 | Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-SClass II · Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread de | Device recalls |
| Sep 30, 2025 | External Fixation Mini Rail SystemK252106 · KTT | 510(k) clearances |
| Dec 21, 2023 | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RClass II · Medical devices distributed, prior to sterilization | Device recalls |
| Dec 21, 2023 | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175LClass II · Medical devices distributed, prior to sterilization | Device recalls |
| Dec 21, 2023 | Phantom TTC Nail, 10.0 X 200mm, RightClass II · Medical devices distributed, prior to sterilization | Device recalls |
| Jul 13, 2022 | Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor SystemClass II · Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
