510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200039Unknown

InSpace Subacromial Tissue Spacer System

Ortho-Space Ltd., Caesarea, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN200039 is the FDA 510(k) clearance record for InSpace Subacromial Tissue Spacer System, a class II device, cleared for Ortho-Space , Ltd. on under FDA product code QPQ (Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed). FDA's definition for product code QPQ reads: "A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears". FDA records list one 510(k) clearance for Ortho-Space , Ltd. As of , FDA records show no recalls naming DEN200039.

Clearance record

Decision date
Received
(395 days to decision)
Product code
QPQ Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
Regulation
21 CFR 888.3630
Device class
Class II
Review panel
Orthopedic
Applicant
Ortho-Space , Ltd. 7 Halamish St., Caesarea, IL
Third party review
No

Clearances, product code QPQ

Trailing 12 months

FDA records hold no clearances under product code QPQ in the trailing twelve months.

FDA records show no clearances under product code QPQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QPQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260