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Medical device manufacturer

Orthopedic Systems, Inc.

Orthopedic Systems, Inc. holds 95 FDA 510(k) clearances across 44 product codes. Median elapsed review time is 28 days. openFDA lists 1 recall record naming the company. FDA publishes it under 2 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
95
Product codes
44
Median review
28 days
Recall records
1

How does FDA spell Orthopedic Systems, Inc.?

FDA publishes this company under 2 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
Orthopedic Systems Incdevice/recallnormalised
Orthopedic Systems, Inc.device/510knormalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Orthopedic Systems, Inc. file in?

44 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
FWZOperating Room Accessories Table Tray820 days
HSTApparatus, Traction, Non-Powered821 days
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented790 days
HRXArthroscope682 days
HWCScrew, Fixation, Bone425 days
KQXGoniometer, Ac-Powered3202 days
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented393 days
GEYMotor, Surgical Instrument, Ac-Powered228 days
HXYBrace, Drill228 days
IKKSystem, Isokinetic Testing And Evaluation228 days
IQMSplint, Temporary Training210 days
ITQJoint, Knee, External Brace217 days
JDGProsthesis, Hip, Femoral Component, Cemented, Metal231 days
JEATable, Surgical With Orthopedic Accessories, Ac-Powered221 days
JEBTable, Surgical With Orthopedic Accessories, Manual211 days
LXHOrthopedic Manual Surgical Instrument249 days
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)130 days
EAJApron, Leaded112 days
FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression151 days
FNJBed, Manual125 days
FSETable, Operating-Room, Manual146 days
FTYTape, Measuring, Rulers And Calipers185 days
FWYTable, Operating-Room, Non-Electrical114 days
FYHSplint, Extremity, Noninflatable, External, Sterile17 days
GEGElevator, Surgical, General & Plastic Surgery122 days

Showing the 25 they file in most, of 44.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Orthopedic Systems, Inc. had a recall?

openFDA lists 1 recall record naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

  • Z-0780-2007TerminatedFWZ

    Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Orthopedic Systems, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMLXH237
K920256SPINE MOTION ANALYZER WITH EMGKQX202
K910736JACKSON MULTIPURPOSE OPERATING TABLEJEA89
K910031PARK CITY SHOULDER POSITIONERFWZ20
K903938C FIT CUPJDI130
K892503NUFFIELD TOTAL KNEEJWH388
K896678SILICONE PLUGHRX64
K894283COMPREHENSIVE SPINE MOTION ANALYZERKQX210
K890498FREEMAN MODULAR HIP STEM RIDGED VERSIONJDI254
K890331FREEMAN TOTAL HIP SYSTEM RIDGED STEMLWJ263

Source: openFDA device/510k · retrieved

Watch what Orthopedic Systems, Inc. files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.