ORACLE SPACER, OPAL SPACER— 510(k) K072791

Name: FDA 510(k) clearance K072791
Creator: U.S. Food and Drug Administration
Published: 2007-12-26

Substantially Equivalent

Synthes Spine

FDA 510(k) clearance K072791 for ORACLE SPACER, OPAL SPACER, Substantially Equivalent on 2007-12-26. Applicant: Synthes Spine. Device class: 2.

Clearance details

Applicant: Synthes Spine
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2007-10-01
Decision date: 2007-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from Synthes Spine

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K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS2012-12-17
K120838 — SYNTHES MATRIX SYSTEM2012-07-31
K111048 — SYNTHES SCOUT TACK FIXATION2012-06-14
K120928 — SYNTHES MATRIX SYSTEM2012-05-18
K120571 — SYNTHES USS CONNECTOR2012-05-14

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K072791

K-number listed on FDA's recall record

Z-1392-2016 — Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.Class II·Terminated·Synthes (USA) Products LLC·20160218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072791.

Data sourced from openFDA. This site is unofficial and independent of the FDA.